Pentalgin-N

Caffeine (Pentalgin-N) and Sodium Benzoate Injection has been used in conjunction with supportive measure to treat respiratory depression associated with overdosage with CNS depressant drugs (e.g., narcotic analgesics, alcohol). However, because of questionable benefit and transient action, most authorities believe Caffeine (Pentalgin-N) and other analeptics should not be used in these conditions and recommend other supportive therapy.

Codeine (Pentalgin-N) sulfate is an opioid analgesic indicated for the management of mild to moderately severe pain where the use of an opioid analgesic is appropriate.

Metamizole (Pentalgin-N) tablets are used for the treatment of pains of different origin and variable intensity: toothache, headache, arthralgia, neuralgia, myositis, mild to moderate visceral pain, high fever, not responding to other drugs.

Carefully consider the potential benefits and risks of Naproxen (Pentalgin-N), Naproxen (Pentalgin-N), ANAPROX, ANAPROX DS or Naproxen (Pentalgin-N) Suspension and other treatment options before deciding to use Naproxen (Pentalgin-N), Naproxen (Pentalgin-N), ANAPROX, ANAPROX DS or Naproxen (Pentalgin-N) Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Naproxen (Pentalgin-N) as Naproxen (Pentalgin-N), Naproxen (Pentalgin-N), ANAPROX, ANAPROX DS or Naproxen (Pentalgin-N) Suspension is indicated:

• For the relief of the signs and symptoms of rheumatoid arthritis
• For the relief of the signs and symptoms of osteoarthritis
• For the relief of the signs and symptoms of ankylosing spondylitis
• For the relief of the signs and symptoms of juvenile arthritis

Naproxen (Pentalgin-N) as Naproxen (Pentalgin-N) Suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight.

Naproxen (Pentalgin-N) as Naproxen (Pentalgin-N) and Naproxen (Pentalgin-N) Suspension is also indicated:

• For relief of the signs and symptoms of tendonitis
• For relief of the signs and symptoms of bursitis
• For relief of the signs and symptoms of acute gout
• For the management of pain
• For the management of primary dysmenorrhea

Naproxen (Pentalgin-N) is not recommended for initial treatment of acute pain because the absorption of Naproxen (Pentalgin-N) is delayed compared to absorption from other Naproxen (Pentalgin-N)-containing products.

Parenteral

1. Sedative. Sedation is obtainable within an hour, and in adequate dosage, the duration of action is more than six hours. Included in the more common conditions in which the sedative action of this class of drugs is desired are anxiety-tension states, hyperthyroidism, essential hypertension, nausea and vomiting of functional origin, motion sickness, acute labyrinthitis, pylorospasm in infants, chorea and cardiac failure. Phenobarbital (Pentalgin-N) is also a useful adjunct in treatment of hemorrhage from the respiratory or gastrointestinal tract. Phenobarbital (Pentalgin-N) controls anxiety, decreases muscular activity and lessens nervous excitability in hyperthyroid patients. However, thyrotoxic individuals occasionally react poorly to barbiturates.
2. Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks.
3. Preanesthetic.
4. Long-term anticonvulsant, (Phenobarbital (Pentalgin-N), mephobarbital and metharbital) for the treatment of generalized tonic-clonic and cortical focal seizures. And, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, cerebral hemorrhage, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics. Phenobarbital (Pentalgin-N) sodium may be administered intramuscularly or intravenously as an anticonvulsant for emergency use. When administered intravenously, it may require 15 or more minutes before reaching peak concentrations in the brain. Therefore, injecting Phenobarbital (Pentalgin-N) sodium until the convulsions stop may cause the brain level to exceed that required to control the convulsions and lead to severe barbiturate-induced depression.
5. Phenobarbital (Pentalgin-N) is indicated in pediatric patients as an anticonvulsant and as a sedative, including its preoperative and postoperative use.

Caffeine (Pentalgin-N) is a central nervous system stimulant. It works by stimulating the brain. Caffeine (Pentalgin-N) is found naturally in foods and beverages such as coffee, tea, colas, energy and chocolate. Botanical sources of Caffeine (Pentalgin-N) include kola nuts, guarana, and yerba mate. Caffeine (Pentalgin-N) is also available in prescription and non-prescription medications.

Caffeine (Pentalgin-N) is used to restore mental alertness or wakefulness during fatigue or drowsiness. Caffeine (Pentalgin-N) is also found in some headache and migraine medications, in certain dietary supplements used for weight loss, and in many popular energy drinks.

Caffeine (Pentalgin-N) (Caffeine (Pentalgin-N)) is available by prescription only. It is used for short-term treatment of neonatal apnea (breathing problems).

Caffeine (Pentalgin-N) may also be used for other conditions as determined by your health care provider.

Codeine (Pentalgin-N) is an opioid pain medication. An opioid is sometimes called a narcotic.

Codeine (Pentalgin-N) is used to treat mild to moderately severe pain.

Codeine (Pentalgin-N) may also be used for purposes not listed in this medication guide.

Naproxen (Pentalgin-N) is a nonsteroidal anti-inflammatory drug (NSAID). Naproxen (Pentalgin-N) works by reducing hormones that cause inflammation and pain in the body.

Naproxen (Pentalgin-N) is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

The delayed-release or extended-release tablets are slower-acting forms of Naproxen (Pentalgin-N) that are used only for treating chronic conditions such as arthritis or ankylosing spondylitis. These forms of Naproxen (Pentalgin-N) will not work fast enough to treat acute pain.

Naproxen (Pentalgin-N) may also be used for purposes not listed in this medication guide.

Phenobarbital (Pentalgin-N) is in a group of drugs called barbiturates (bar-BIT-chur-ates). Phenobarbital (Pentalgin-N) slows the activity of your brain and nervous system.

Phenobarbital (Pentalgin-N) is used to treat or prevent seizures. It is also used short-term to treat insomnia, or as a sedative before surgery.

Phenobarbital (Pentalgin-N) may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Drowsiness:

100 to 200 mg orally not more often than every 3 to 4 hours.

For occasional use only.

Not intended for use as a substitute for sleep.

Limit the use of Caffeine (Pentalgin-N) containing medications, foods, or beverages while taking this product because too much Caffeine (Pentalgin-N) may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Usual Pediatric Dose for Drowsiness:

>= 12 years: 100 to 200 mg not more often than every 3 to 4 hours.

For occasional use only.

Not intended for use as a substitute for sleep.

Limit the use of Caffeine (Pentalgin-N) containing medications, foods, or beverages while taking this product because too much Caffeine (Pentalgin-N) may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Usual Pediatric Dose for Apnea of Prematurity:

For short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.

Prior to initiation of Caffeine (Pentalgin-N), baseline serum levels of Caffeine (Pentalgin-N) should be measured in infants previously treated with theophylline, since preterm infants metabolize theophylline to Caffeine (Pentalgin-N). Likewise, baseline serum levels of Caffeine (Pentalgin-N) should be measured in infants born to mothers who consumed Caffeine (Pentalgin-N) prior to delivery, since Caffeine (Pentalgin-N) readily crosses the placenta.

Loading Dose: 20 mg/kg Caffeine (Pentalgin-N) intravenous (over 30 minutes) once

Maintenance Dose: 5 mg/kg Caffeine (Pentalgin-N) intravenous (over 10 minutes) or orally every 24 hours.

Note: The dose of Caffeine (Pentalgin-N) base is one-half the dose when expressed as Caffeine (Pentalgin-N) (e.g., 20 mg of Caffeine (Pentalgin-N) is equivalent to 10 mg of Caffeine (Pentalgin-N) base).

Serum concentrations of Caffeine (Pentalgin-N) may need to be monitored periodically throughout treatment to avoid toxicity. Serious toxicity has been associated with serum levels greater than 50 mg/L.

Apnea of prematurity is a diagnosis of exclusion. Other causes of apnea (e.g., central nervous system disorders, primary lung disease, anemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnea) should be ruled out or properly treated prior to initiation of Caffeine (Pentalgin-N).

Caffeine (Pentalgin-N) should be used with caution in infants with seizure disorders or cardiovascular disease.

The duration of treatment of apnea of prematurity in the placebo-controlled trial was limited to 10 to 12 days. The safety and efficacy of Caffeine (Pentalgin-N) for longer periods of treatment have not been established.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet,

Oral, as sulfate:

Generic: 15 mg, 30 mg, 60 mg

Dosing: Adult

Pain management (analgesic):

Injection [Canadian product]:

Opioid-naive patients: IM, SubQ: 30 to 60 mg every 4 to 6 hours as needed (use the lowest effective dose for the shortest period of time necessary)

Conversion from oral Codeine (Pentalgin-N) or another opioid: IM, SubQ: Refer to product labeling for dose conversions.

Oral: Note:

Immediate release (tablet, oral solution [Canadian product]): Initial: 15 to 60 mg every 4 hours as needed; maximum total daily dose: 360 mg/day; patients with prior opioid exposure may require higher initial doses. Note: The American Pain Society recommends an initial dose of 30 to 60 mg for adults with moderate pain (American Pain Society 2016).

Controlled release: Codeine (Pentalgin-N) Contin [Canadian product]: Note: Titrate at intervals of ≥48 hours until adequate analgesia has been achieved. Daily doses >600 mg/day should not be used; patients requiring higher doses should be switched to an opioid approved for use in severe pain. In patients who receive both Codeine (Pentalgin-N) Contin and an immediate release or combination Codeine (Pentalgin-N) product for breakthrough pain, the rescue dose of immediate release Codeine (Pentalgin-N) product should be ≤12.5% of the total daily Codeine (Pentalgin-N) Contin dose.

Opioid-naive patients: Initial: 50 mg every 12 hours

Conversion from immediate release Codeine (Pentalgin-N) preparations: Immediate release Codeine (Pentalgin-N) preparations contain ~75% Codeine (Pentalgin-N) base. Therefore, patients who are switching from immediate release Codeine (Pentalgin-N) preparations may be transferred to a ~25% lower total daily dose of Codeine (Pentalgin-N) Contin, equally divided into 2 daily doses every 12 hours.

Conversion from a combination Codeine (Pentalgin-N) product (eg, Codeine (Pentalgin-N) with acetaminophen or Codeine (Pentalgin-N)): See table:

Conversion from another opioid analgesic: Using the patient's current opioid dose, calculate an equivalent daily dose of immediate release Codeine (Pentalgin-N). A ~25% lower dose of Codeine (Pentalgin-N) Contin should then be initiated, equally divided into 2 daily doses.

Discontinuation of therapy: When discontinuing chronic opioid therapy, the dose should be gradually tapered down. An optimal universal tapering schedule for all patients has not been established (CDC [Dowell 2016]). Proposed schedules range from slow (eg, 10% reductions per week) to rapid (eg, 25% to 50% reduction every few days) (CDC 2015). Tapering schedules should be individualized to minimize opioid withdrawal while considering patient-specific goals and concerns as well as the pharmacokinetics of the opioid being tapered. An even slower taper may be appropriate in patients who have been receiving opioids for a long duration (eg, years), particularly in the final stage of tapering, whereas more rapid tapers may be appropriate in patients experiencing severe adverse events (CDC [Dowell 2016]). Monitor carefully for signs/symptoms of withdrawal. If the patient displays withdrawal symptoms, consider slowing the taper schedule; alterations may include increasing the interval between dose reductions, decreasing amount of daily dose reduction, pausing the taper and restarting when the patient is ready, and/or coadministration of an alpha-2 agonist (eg, clonidine) to blunt withdrawal symptoms (Berna 2015; CDC [Dowell 2016]). Continue to offer nonopioid analgesics as needed for pain management during the taper; consider nonopioid adjunctive treatments for withdrawal symptoms (eg, GI complaints, muscle spasm) as needed (Berna 2015; Sevarino 2018).

Cough in select patients (off-label use):

Oral: Reported doses vary with a range of 7.5 to 120 mg/day as a single dose or in divided doses; however, evidence is of low quality (ACCP [Bolser 2006]; Smith 2010). Some experts recommend 30 to 60 mg 4 times daily in specific patient populations (eg, lung cancer) (ACCP [Molassiotis 2017]). Additional data may be necessary to further define the role of Codeine (Pentalgin-N) in this condition.

Diarrhea (persistent) (palliative care) (off-label use):

Oral: 15 to 30 mg every 4 hours as needed (von Gunten 2013). Additional data may be necessary to further define the role of Codeine (Pentalgin-N) in this condition.

Restless leg syndrome (off-label use):

Oral: Initial: 30 mg once daily at bedtime or during the night; may increase to 60 mg if needed; maximum dose: 180 mg in 2 to 3 divided doses. May be used alone or in combination with other medications used to treat RLS (Earley 2003; Sandyk 1987; Silbers 2013; Walters 2001).

Dosing: Geriatric

Refer to adult dosing. Use with caution and consider initiation at the low end of the dosing range; reduced initial dosages may be necessary.

Dosing: Pediatric

Note: Codeine (Pentalgin-N) 30 mg/5 mL oral solution has been discontinued in the US for more than 1 year. Doses should be titrated to appropriate analgesic effect; use the lowest effective dose for the shortest period of time:

Pain management; analgesia: Limited data available: Note: Use is contraindicated in pediatric patients <12 years of age and for postoperative management in pediatric patients 12 to 18 years of age who have undergone tonsillectomy and/or adenoidectomy. Avoid Codeine (Pentalgin-N) use in all pediatric patient populations in which it is contraindicated and in pediatric patients 12 to 18 years of age who have other risk factors that increase risk for respiratory depression associated with Codeine (Pentalgin-N) (eg, conditions associated with hypoventilation like postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, use of other medications known to depress respiratory drive); in rare cases in which Codeine (Pentalgin-N)-containing product is the only option, consider genotype testing prior to use; use extra precaution; monitor closely for adverse effects. Codeine (Pentalgin-N) has been associated with reports of life-threatening or fatal respiratory depression in children and adolescents; multifactorial causes have been identified; of primary concern are unrecognized ultrarapid metabolizers of CYP2D6 who may have extensive conversion of Codeine (Pentalgin-N) (prodrug) to morphine and thus increased opioid-mediated effects. Avoid Codeine (Pentalgin-N) use in pediatric patient populations in which it is contraindicated; in rare cases in which Codeine (Pentalgin-N)-containing product is the only option, consider genotype testing prior to use; use extra precaution; monitor closely for adverse effects (AAP [Tobias 2016]; Dancel 2017; Gammal 2016; Goldschneider 2017; Poonai 2015).

Children and Adolescents:

Oral: 0.5 to 1 mg/kg/dose every 4 to 6 hours as needed; maximum single dose: 60 mg/dose (APS 2016)

The dosing regimen of Metamizole (Pentalgin-N) is individual. When this medication is administered orally of the single dose is 20-40 mg. The daily dose is 20-80 mg, the frequency of use is 1-2 times / day. The duration of treatment is 2-8 weeks.

Usual Adult Dose for Ankylosing Spondylitis:

Initial: 250 mg to 500 mg (Naproxen (Pentalgin-N)) or 275 mg to 550 mg (Naproxen (Pentalgin-N) sodium) orally twice a day. The initial dose for Naproxen (Pentalgin-N) sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day.

Maintenance: May be increased to a daily maximum of 1500 mg (Naproxen (Pentalgin-N)) or 1650 mg (Naproxen (Pentalgin-N) sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of Naproxen (Pentalgin-N) sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods.

Usual Adult Dose for Osteoarthritis:

Initial: 250 mg to 500 mg (Naproxen (Pentalgin-N)) or 275 mg to 550 mg (Naproxen (Pentalgin-N) sodium) orally twice a day. The initial dose for Naproxen (Pentalgin-N) sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day.

Maintenance: May be increased to a daily maximum of 1500 mg (Naproxen (Pentalgin-N)) or 1650 mg (Naproxen (Pentalgin-N) sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of Naproxen (Pentalgin-N) sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods.

Usual Adult Dose for Rheumatoid Arthritis:

Initial: 250 mg to 500 mg (Naproxen (Pentalgin-N)) or 275 mg to 550 mg (Naproxen (Pentalgin-N) sodium) orally twice a day. The initial dose for Naproxen (Pentalgin-N) sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day.

Maintenance: May be increased to a daily maximum of 1500 mg (Naproxen (Pentalgin-N)) or 1650 mg (Naproxen (Pentalgin-N) sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of Naproxen (Pentalgin-N) sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods.

Usual Adult Dose for Acute Gout:

750 mg (Naproxen (Pentalgin-N)) or 825 mg (Naproxen (Pentalgin-N) sodium) orally one time, followed by 250 mg (Naproxen (Pentalgin-N)) or 275 mg (Naproxen (Pentalgin-N) sodium) every 8 hours until the gouty attack has resolved, usually 2 to 3 days. The recommended dose of Naproxen (Pentalgin-N) sodium controlled-release is two to three 500 mg tablets (1000 to 1500 mg) orally on the first day, followed by two 500 mg tablets (1000 mg) orally daily until the attack has subsided.

Usual Adult Dose for Bursitis:

550 mg Naproxen (Pentalgin-N) sodium orally once, followed by 550 mg Naproxen (Pentalgin-N) sodium every 12 hours, or 275 mg (Naproxen (Pentalgin-N) sodium)/250 mg (Naproxen (Pentalgin-N)) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Naproxen (Pentalgin-N) sodium or 1000 mg Naproxen (Pentalgin-N). The recommended initial dose of Naproxen (Pentalgin-N) sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).

Usual Adult Dose for Tendonitis:

550 mg Naproxen (Pentalgin-N) sodium orally once, followed by 550 mg Naproxen (Pentalgin-N) sodium every 12 hours, or 275 mg (Naproxen (Pentalgin-N) sodium)/250 mg (Naproxen (Pentalgin-N)) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Naproxen (Pentalgin-N) sodium or 1000 mg Naproxen (Pentalgin-N). The recommended initial dose of Naproxen (Pentalgin-N) sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).

Usual Adult Dose for Dysmenorrhea:

550 mg Naproxen (Pentalgin-N) sodium orally once, followed by 550 mg Naproxen (Pentalgin-N) sodium every 12 hours, or 275 mg (Naproxen (Pentalgin-N) sodium)/250 mg (Naproxen (Pentalgin-N)) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Naproxen (Pentalgin-N) sodium or 1000 mg Naproxen (Pentalgin-N).

Over-the-counter preparation: Naproxen (Pentalgin-N) sodium 220 mg orally every 8 hours as needed. Do not exceed 2 caplets in any 8- to 12-hour period.

The recommended initial dose of Naproxen (Pentalgin-N) sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).

Usual Adult Dose for Pain:

550 mg Naproxen (Pentalgin-N) sodium orally once, followed by 550 mg Naproxen (Pentalgin-N) sodium every 12 hours, or 275 mg (Naproxen (Pentalgin-N) sodium)/250 mg (Naproxen (Pentalgin-N)) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Naproxen (Pentalgin-N) sodium or 1000 mg Naproxen (Pentalgin-N).

Over-the-counter preparation: Naproxen (Pentalgin-N) sodium 220 mg orally every 8 hours as needed. Do not exceed 2 caplets in any 8- to 12-hour period.

The recommended initial dose of Naproxen (Pentalgin-N) sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).

Usual Geriatric Dose for Pain:

Over-the-counter preparation - 220 mg (Naproxen (Pentalgin-N) sodium) orally every 12 hours or 250 mg (Naproxen (Pentalgin-N)) orally every 8 hours as needed.

Usual Pediatric Dose for Fever:

Dosage guidelines are based on Naproxen (Pentalgin-N):

Greater than 2 years: 2.5 to 10 mg/kg/dose. Maximum daily dose is 10 mg/kg, given every 8 to 12 hours.

Usual Pediatric Dose for Pain:

Dosage guidelines are based on Naproxen (Pentalgin-N):

Greater than 2 years: 2.5 to 10 mg/kg/dose. Maximum daily dose is 10 mg/kg, given every 8 to 12 hours.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:

Dosage guidelines are based on Naproxen (Pentalgin-N):

Greater than or equal to 2 years: 5 mg/kg orally twice a day. Maximum dose: 1000 mg/day.

Suggested doses of Phenobarbital (Pentalgin-N) for specific indications are as follows:

a. Pediatric

Oral Dosage (as recommended by the American Academy of Pediatrics):

Preoperative: 1 to 3 mg/kg.

b. Adult

Oral

Dosage:

Dosages of Phenobarbital (Pentalgin-N) must be individualized with full knowledge of their particular characteristics and recommended rate of administration. Factors of consideration are the patient's age, weight, and condition.

Parenteral routes should be used only when oral administration is impossible or impractical.

Anticonvulsant use: A therapeutic anticonvulsant level of Phenobarbital (Pentalgin-N) in serum is 10 to 25 µg/mL. To achieve the blood levels considered therapeutic in children, higher per-kilogram dosages are generally necessary for Phenobarbital (Pentalgin-N) and most other anticonvulsants. In children and infants, Phenobarbital (Pentalgin-N) at loading dose of 15 to 20 mg/kg produces blood levels of about 20 µg/mL shortly after administration.

In status epilepticus, it is imperative to achieve therapeutic blood levels of Phenobarbital (Pentalgin-N) as rapidly as possible. Because a barbiturate-induced depression may occur along with a postictal depression once the seizures are controlled, it is important, therefore, to use the minimal amount required, and to wait for the anticonvulsant effect to develop before administering a second dose.

Phenobarbital (Pentalgin-N) has been used in the treatment and prophylaxis of febrile seizures. However, it has not been established that prevention of febrile seizures influences the subsequent development of epilepsy.

Special patient population: Dosage should be reduced in the elderly or debilitated because these patients may be more sensitive to Phenobarbital (Pentalgin-N). Dosage should be reduced for patients with impaired renal function or hepatic disease.

How supplied

Oral Tablets

15 mg - Each white round tablet imprinted Þ 026 contains 15 mg of Phenobarbital (Pentalgin-N). Tablets are supplied in bottles of 1000 (NDC 0228-2026-96).

30 mg - Each white, round, scored tablet imprinted Þ 028 contains 30 mg of Phenobarbital (Pentalgin-N). Tablets are supplied in bottles of 1000 (NDC 0228-2028-96).

100 mg - Each white, round, scored tablet imprinted Þ 030 contains 100 mg of Phenobarbital (Pentalgin-N). Tablets are supplied in bottles of 1000 (NDC 0228-2030-96).

Dispense in well-closed containers as defined in the USP. Store at controlled room temperature 15º- 30º C (59º- 86º F).

Oral Elixir

Red, clear elixir contains 20 mg of Phenobarbital (Pentalgin-N) per teaspoon (5 ml). Alcohol 13% by volume. Elixir is supplied in pints (NDC 0228-2024-16).

Preserve and dispense in tight, light- resistant containers as defined in the USP. Store at controlled room temperature 15º- 30ºC (59º- 86º F).

Rx only.

See also:
What is the most important information I should know about Caffeine (Pentalgin-N)?

Caffeine (Pentalgin-N) should not be given to a child who has had an allergic reaction to it in the past.

Before using Caffeine (Pentalgin-N), tell the doctor if your child is allergic to any drugs, or has a seizure disorder, heart disease, kidney disease, liver disease, or high or low blood sugar.

Do not use the medication for longer than 12 days without the advice of your child's doctor.

Each bottle of Caffeine (Pentalgin-N) is for one use only, even if your child does not use the entire bottle for a single dose. Throw away any medication left over in the bottle after measuring your child's dose.

Call your doctor if the child's breathing symptoms do not improve after using Caffeine (Pentalgin-N).

To be sure Caffeine (Pentalgin-N) is helping your child's condition, the child's blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

See also:
What is the most important information I should know about Codeine (Pentalgin-N)?

Codeine (Pentalgin-N) Sulfate is contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy​​.

Codeine (Pentalgin-N) Sulfate is contraindicated in patients with known hypersensitivity to Codeine (Pentalgin-N) or any components of the product. Persons known to be hypersensitive to certain other opioids may exhibit cross-sensitivity to Codeine (Pentalgin-N).

Codeine (Pentalgin-N) Sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment​​.

Codeine (Pentalgin-N) Sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia.

Codeine (Pentalgin-N) Sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus.

Active gastroduodenal ulcer, liver failure, hepatitis, nephritis, blood dyscrasias, cardiac failure, oliguria. Do not be administered for prolonged periods. Metamizole (Pentalgin-N) magnesium (Metamizole (Pentalgin-N)) has not administered in case of allergy to pyrazolone (eg, hypersensitivity to drugs with Metamizole (Pentalgin-N) magnesium, isopirina, propyphenazone, phenazone or phenylbutazone), and certain metabolic disorders (hepatic porphyria, congenital deficiency of glucose-6-phosphate dehydrogenase), patients with hypersensitivity to analgesics (pain relievers asthma) infants during the first three months and less than 5 kg of weight, patients with blood pressure below 100 mm Hg or movement unstable hematopoiesis and injured patients.

See also:
What is the most important information I should know about Naproxen (Pentalgin-N)?

Naproxen (Pentalgin-N), Naproxen (Pentalgin-N), ANAPROX, ANAPROX DS and Naproxen (Pentalgin-N) Suspension are contraindicated in patients with known hypersensitivity to Naproxen (Pentalgin-N) and Naproxen (Pentalgin-N) sodium.

Naproxen (Pentalgin-N), Naproxen (Pentalgin-N), ANAPROX, ANAPROX DS and Naproxen (Pentalgin-N) Suspension should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking Naproxen (Pentalgin-N) or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.

Naproxen (Pentalgin-N), Naproxen (Pentalgin-N), ANAPROX, ANAPROX DS and Naproxen (Pentalgin-N) Suspension are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

See also:
What is the most important information I should know about Phenobarbital (Pentalgin-N)?

Do not use Phenobarbital (Pentalgin-N) if you are pregnant. It could harm the unborn baby. Phenobarbital (Pentalgin-N) may also cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy.

Phenobarbital (Pentalgin-N) can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking Phenobarbital (Pentalgin-N).

Phenobarbital (Pentalgin-N) may cause a severe allergic reaction. Stop taking Phenobarbital (Pentalgin-N) and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Do not stop using Phenobarbital (Pentalgin-N) without first talking to your doctor, even if you feel better. You may have increased seizures if you stop using Phenobarbital (Pentalgin-N) suddenly. You will need to use less and less before you stop the medication completely.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Phenobarbital (Pentalgin-N) and talk with your doctor about another treatment for your sleep disorder.

Phenobarbital (Pentalgin-N) may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

Use Caffeine (Pentalgin-N) as directed by your health care provider. If the medication is OTC, check the label on the bottle for the exact dosing instructions. If you have any questions about the use of an OTC medication, ask your pharmacist.

• Caffeine (Pentalgin-N) may be taken with or without food. If Caffeine (Pentalgin-N) upsets your stomach, take it with food.
• Do not exceed the recommended dose of Caffeine (Pentalgin-N). Caffeine (Pentalgin-N) can be habit-forming.
• Most OTC medications used for mental alertness contain 200 milligrams of Caffeine (Pentalgin-N) per tablet or capsule. The usual maximum recommended dose of OTC Caffeine (Pentalgin-N) is no more than 200 mg every 3-4 hours, or 1600 mg per day.
• Do not double-up on your Caffeine (Pentalgin-N) dose if you should miss the time for next dose.
• The average cup of coffee contains 150-200 milligrams (mg) of Caffeine (Pentalgin-N) per cup, while a cup of tea will have about 60 mg of Caffeine (Pentalgin-N). Cola products have about 30-40 mg of Caffeine (Pentalgin-N), and most energy drinks have about 60-70 mg. Be sure to account for any dietary Caffeine (Pentalgin-N) that is consumed.

Ask your health care provider any questions you may have about how to use Caffeine (Pentalgin-N).

Use Naproxen (Pentalgin-N) sustained-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Naproxen (Pentalgin-N) sustained-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Naproxen (Pentalgin-N) sustained-release tablets refilled.
• Swallow Naproxen (Pentalgin-N) sustained-release tablets whole. Do not break, crush, or chew before swallowing.
• Take Naproxen (Pentalgin-N) sustained-release tablets by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
• Take Naproxen (Pentalgin-N) sustained-release tablets with a full glass of water (8 oz [240 mL]) as directed by your doctor.
• If you take antacids, cholestyramine, or sucralfate, ask your doctor or pharmacist how to take them with Naproxen (Pentalgin-N) sustained-release tablets.
• If you miss a dose of Naproxen (Pentalgin-N) sustained-release tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Naproxen (Pentalgin-N) sustained-release tablets.

Use Phenobarbital (Pentalgin-N) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Phenobarbital (Pentalgin-N) is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Phenobarbital (Pentalgin-N) at home, a health care provider will teach you how to use it. Be sure you understand how to use Phenobarbital (Pentalgin-N). Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Phenobarbital (Pentalgin-N) if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Do not suddenly stop using Phenobarbital (Pentalgin-N) or change the dose without checking with your doctor.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Phenobarbital (Pentalgin-N), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Phenobarbital (Pentalgin-N).

Use: Labeled Indications

Immediate release:

Analgesic, antipyretic, and anti-inflammatory: For the temporary relief of headache, pain, and fever caused by colds, muscle aches and pains, menstrual pain, toothache pain, and minor aches and pains of arthritis.

Revascularization procedures: For use in patients who have undergone revascularization procedures (ie, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or carotid endarterectomy).

Vascular indications, including ischemic stroke, transient ischemic attack, acute coronary syndromes (ST-elevation myocardial infarction or non-ST-elevation acute coronary syndromes [non-ST-elevation myocardial infarction or unstable angina]), secondary prevention after acute coronary syndromes, and management of stable ischemic heart disease: To reduce the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli; to reduce the risk of vascular mortality in patients with a suspected acute myocardial infarction (MI); to reduce the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina; to reduce the combined risk of MI and sudden death in patients with stable ischemic heart disease.

ER capsules:

Ischemic stroke or transient ischemic attack: To reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack.

Stable ischemic heart disease: To reduce the risk of death and MI in patients with stable ischemic heart disease.

Limitations of use: Do not use ER capsules in situations for which a rapid onset of action is required (such as acute treatment of MI or before percutaneous coronary intervention); use IR formulations instead.

Off Label Uses

Atherosclerotic cardiovascular disease, primary prevention

Based on the 2019 American College of Cardiology/American Heart Association (ACC/AHA) guideline on the primary prevention of cardiovascular disease and the 2020 American Diabetes Association standards of medical care in diabetes, Caffeine (Pentalgin-N) may be used for the primary prevention of cardiovascular disease in select patients after weighing the cardiovascular disease risk versus benefits.

Carotid artery atherosclerosis, asymptomatic or symptomatic

Based on the 2012 American College of Chest Physicians (ACCP) guidelines for antithrombotic therapy and prevention of thrombosis (9th edition), daily Caffeine (Pentalgin-N) is suggested in patients with asymptomatic or symptomatic carotid artery atherosclerosis based on a slight reduction in total mortality observed when Caffeine (Pentalgin-N) is taken over 10 years (regardless of cardiovascular risk profile). The AHA/American Stroke Association guidelines for the primary prevention of stroke recommend daily Caffeine (Pentalgin-N) for patients with asymptomatic or symptomatic carotid atherosclerosis to reduce the risk of a first stroke.

Carotid artery stenting

A randomized, controlled trial with blinded end point adjudication evaluated carotid artery stenting versus carotid endarterectomy in patients with carotid artery stenosis. In this trial, Caffeine (Pentalgin-N) in combination with clopidogrel was used for patients who underwent carotid artery stenting, which suggests that this antiplatelet combination is effective.

Use: Labeled Indications

Pain management: Management of mild- to moderately-severe pain

Limitations of use: Reserve Codeine (Pentalgin-N) for use in patients for whom alternative treatment options (eg, nonopioid analgesics, opioid combination products) are ineffective, not tolerated, or would be otherwise inadequate.

Off Label Uses

Cough in select patients

In a metaanalysis of trials evaluating the treatment of chronic cough, the use of Codeine (Pentalgin-N) demonstrated efficacy in patients with this condition.

Metamizole (Pentalgin-N) is used to treat pain of different origins such as toothache, headache, visceral pain or high fever. It is also used to treat severe pain associated with surgeries, cancer or stomach problems.

Naproxen (Pentalgin-N) is used to relieve mild to moderate pain from various conditions. It also reduces pain, swelling, and joint stiffness from arthritis. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation.

If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

This form of Naproxen (Pentalgin-N) is absorbed slowly and should not be used for pain that needs quick relief (such as during a gout attack). Ask your doctor or pharmacist about using a different form of this drug or other medications for quick relief of pain.

How to use Naproxen (Pentalgin-N)

Read the Medication Guide provided by your pharmacist before you start using Naproxen (Pentalgin-N) and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually twice daily with or without food. Swallow this medication whole. Do not break, crush, or chew the tablets. Doing so can release the drug too quickly, increasing the risk of side effects. Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this drug.

The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or take this drug more often than directed. For ongoing conditions such as arthritis, continue taking this medication as directed by your doctor.

For certain conditions (such as arthritis), it may take up to two weeks of taking this drug regularly until you get the full benefit.

Tell your doctor if your condition does not improve or if it worsens.

This medication is used alone or with other medications to control seizures. Controlling and reducing seizures lets you do more of your normal daily activities, reduces your risk of harm when you lose consciousness, and lessens your risk for a possibly life-threatening condition of frequent, repeated seizures. Phenobarbital (Pentalgin-N) belongs to a class of drugs known as barbiturate anticonvulsants/hypnotics. It works by controlling the abnormal electrical activity in the brain that occurs during a seizure. This medication is also used for a short time (usually no more than 2 weeks) to help calm you or help you sleep during periods of anxiety. It works by affecting certain parts of the brain to cause calming.

How to use Phenobarbital (Pentalgin-N)

Take this medication by mouth with or without food, usually once daily at bedtime for seizure control, or as directed by your doctor. Take with food or milk if stomach upset occurs. If you are using the liquid form of this medication, measure the dose carefully using a special measuring device/cup. Do not use a household spoon because you may not get the correct dose.

Dosage is based on your medical condition, Phenobarbital (Pentalgin-N) blood levels, and response to treatment. The dosage in children may also be based on weight.

Your doctor may direct you to start this medication at a low dose and gradually increase your dose to prevent side effects such as drowsiness and dizziness. Follow your doctor's instructions carefully. Do not take more or less of this drug than prescribed.

It may take several weeks to reach the best dose for you and completely control your seizures. This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take it at the same time(s) each day.

Do not stop taking this medication (and other anticonvulsant medications) without consulting your doctor. Your seizures may worsen or cause a very severe seizure that is difficult to treat (status epilepticus) when this drug is suddenly stopped.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as anxiety, hallucinations, twitching, trouble sleeping) may occur if you suddenly stop using this medication. Withdrawal from Phenobarbital (Pentalgin-N) can be severe and include seizures and (rarely) death. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

When this medication is used for a long time for anxiety or to help you sleep, it may not work as well. Phenobarbital (Pentalgin-N) should only be used for a short time for anxiety or sleep. Talk with your doctor if this medication stops working well.

Tell your doctor if your anxiety or seizure control worsens (such as the number of seizures increases).

See also:
What other drugs will affect Caffeine (Pentalgin-N)?

Acebrophylline: May enhance the stimulatory effect of CNS Stimulants. Avoid combination

Adenosine: Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products may diminish the therapeutic effect of Adenosine. Management: Monitor for decreased effect of adenosine if patient is receiving Caffeine (Pentalgin-N). Discontinue Caffeine (Pentalgin-N) in advance of scheduled diagnostic use of adenosine whenever possible. Consider therapy modification

Amifampridine: Agents With Seizure Threshold Lowering Potential may enhance the neuroexcitatory and/or seizure-potentiating effect of Amifampridine. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Broccoli: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Monitor therapy

Bromperidol: Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products may decrease the absorption of Bromperidol. Monitor therapy

BuPROPion: May enhance the neuroexcitatory and/or seizure-potentiating effect of Agents With Seizure Threshold Lowering Potential. Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Cannabis: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Monitor therapy

CloZAPine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of CloZAPine. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

CYP1A2 Inducers (Moderate): May decrease the serum concentration of Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products. Monitor therapy

CYP1A2 Inhibitors (Moderate): May increase the serum concentration of Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products. Monitor therapy

CYP1A2 Inhibitors (Strong): May increase the serum concentration of Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products. Monitor therapy

Doxofylline: Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products may enhance the adverse/toxic effect of Doxofylline. Avoid combination

Esketamine: May enhance the hypertensive effect of CNS Stimulants. Monitor therapy

Formoterol: Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products may enhance the adverse/toxic effect of Formoterol. Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products may enhance the hypokalemic effect of Formoterol. Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy

Indacaterol: Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products may enhance the adverse/toxic effect of Indacaterol. Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products may enhance the hypokalemic effect of Indacaterol. Monitor therapy

Iohexol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Iomeprol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Iopamidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

Lithium: Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products may decrease the serum concentration of Lithium. Monitor therapy

Norfloxacin: May increase the serum concentration of Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products. Monitor therapy

Olodaterol: Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products may enhance the adverse/toxic effect of Olodaterol. Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products may enhance the hypokalemic effect of Olodaterol. Monitor therapy

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Consider therapy modification

Pipemidic Acid: May increase the serum concentration of Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products. Monitor therapy

Regadenoson: Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products may diminish the vasodilatory effect of Regadenoson. Management: Avoiding using Caffeine (Pentalgin-N) or other methylxanthine containing products (e.g., theophylline) for at least 12 hours prior to the administration of regadenoson. Consider therapy modification

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Monitor therapy

Solriamfetol: CNS Stimulants may enhance the hypertensive effect of Solriamfetol. CNS Stimulants may enhance the tachycardic effect of Solriamfetol. Monitor therapy

Stiripentol: May increase the serum concentration of Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products. Avoid combination

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Theophylline Derivatives: CYP1A2 Inhibitors (Weak) may increase the serum concentration of Theophylline Derivatives. Exceptions: Dyphylline. Monitor therapy

TiZANidine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of TiZANidine. Management: Avoid these combinations when possible. If combined use is necessary, initiate tizanidine at an adult dose of 2 mg and increase in 2 to 4 mg increments based on patient response. Monitor for increased effects of tizanidine, including adverse reactions. Consider therapy modification

Tobacco (Smoked): May decrease the serum concentration of Caffeine (Pentalgin-N) and Caffeine (Pentalgin-N) Containing Products. Monitor therapy

See also:
What other drugs will affect Codeine (Pentalgin-N)?

When this drug applied simultaneously with:

- drugs have a depressing effect on the central nervous system (including those with opioid analgesics, barbiturates, benzodiazepines, clonidine) it is possible an increase the action of Codeine (Pentalgin-N).

- derivatives of morphine it may increased the inhibitory action on the respiratory center; ibuprofen - analgesic effect is enhanced; carbamazepine - it may increased the analgesic effect is apparently due to increased formation of Codeine (Pentalgin-N) metabolite normorphine, which has a stronger effect.

- quinidine the analgesic effect of Codeine (Pentalgin-N) decreased or almost disappeared.

- Codeine (Pentalgin-N) increases the effect of ethanol on psychomotor function.

With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic action of paracetamol.

With the simultaneous use of anticoagulants may be slight to moderate increase in prothrombin time.

With the simultaneous use of anticholinergics may decrease absorption of paracetamol.

With the simultaneous use of oral contraceptives accelerated excretion of paracetamol from the body and may reduce its analgesic action.

With the simultaneous use with urological means reduced their effectiveness.

With the simultaneous use of activated charcoal reduced bioavailability of paracetamol.

When Metamizole (Pentalgin-N) Mount Mettur Pharmaceuticals applied simultaneously with diazepam may decrease excretion of diazepam.

There have been reports about the possibility of enhancing mielodepression effect of zidovudine while applying with paracetamol. A case of severe toxic liver injury.

Described cases of toxic effects of paracetamol, while the use of isoniazid.

When applied simultaneously with carbamazepine, phenytoin, phenobarbital, primidonom decreases the effectiveness of paracetamol, which is caused by an increase in its metabolism and excretion from the body. Cases of hepatotoxicity, while the use of paracetamol and phenobarbital.

In applying cholestyramine a period of less than 1 h after administration of paracetamol may decrease of its absorption.

At simultaneous application with lamotrigine moderately increased excretion of lamotrigine from the body.

With the simultaneous use of metoclopramide may increase absorption of paracetamol and its increased concentration in blood plasma.

When applied simultaneously with probenecid may decrease clearance of paracetamol, with rifampicin, sulfinpyrazone - may increase clearance of paracetamol due to increasing its metabolism in the liver.

At simultaneous application of Metamizole (Pentalgin-N) Mount Mettur Pharmaceuticals with ethinylestradiol increases absorption of paracetamol from the gut.

Enhances the effect of indirect anticoagulants (coumarin derivatives and indandione). Antipyretic and analgesic activity of Metamizole (Pentalgin-N) increases, reduce - rifampicin, phenobarbital and alcohol (accelerated biotransformation, inducing microsomal liver enzymes).

See also:
What other drugs will affect Naproxen (Pentalgin-N)?

The use of NSAIDs in patients who are receiving ACE inhibitors may potentiate renal disease states.

In vitro studies have shown that Naproxen (Pentalgin-N) anion, because of its affinity for protein, may displace from their binding sites other drugs which are also albumin-bound.

Theoretically, the Naproxen (Pentalgin-N) anion itself could likewise be displaced. Short-term controlled studies failed to show that taking the drug significantly affects prothrombin times when administered to individuals on coumarin-type anticoagulants. Caution is advised nonetheless, since interactions have been seen with other nonsteroidal agents of this class. Similarly, patients receiving the drug and a hydantoin, sulfonamide or sulfonylurea should be observed for signs of toxicity to these drugs.

Concomitant administration of Naproxen (Pentalgin-N) and Naproxen (Pentalgin-N) is not recommended because Naproxen (Pentalgin-N) is displaced from its binding sites during the concomitant administration of Naproxen (Pentalgin-N), resulting in lower plasma concentrations and peak plasma levels.

The natriuretic effect of furosemide has been reported to be inhibited by some drugs of this class. Inhibition of renal lithium clearance leading to increases in plasma lithium concentrations has also been reported. Naproxen (Pentalgin-N) and other NSAIDs can reduce the antihypertensive effect of propranolol and other beta-blockers.

Probenecid given concurrently increases Naproxen (Pentalgin-N) anion plasma levels and extends its plasma half-life significantly.

Caution should be used if Naproxen (Pentalgin-N) is administered concomitantly with methotrexate. Naproxen (Pentalgin-N), Naproxen (Pentalgin-N) sodium and other NSAIDs have been reported to reduce the tubular secretion of methotrexate in an animal model, possibly increasing the toxicity of methotrexate.

Drug/Laboratory Test Interactions

Naproxen (Pentalgin-N) may decrease platelet aggregation and prolong bleeding time. This effect should be kept in mind when bleeding times are determined. The administration of Naproxen (Pentalgin-N) may result in increased urinary values for 17-ketogenic steroids because of an interaction between the drug and/or its metabolites with m-dinitrobenzene used in this assay. Although 17-hydroxy-corticosteroid measurements (Porter-Silber test) do not appear to be artifactually altered, it is suggested that therapy with Naproxen (Pentalgin-N) be temporarily discontinued 72 hours before adrenal function tests are performed if the Porter-Silber test is to be used.

Naproxen (Pentalgin-N) may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA).

See also:
What other drugs will affect Phenobarbital (Pentalgin-N)?

Most reports of clinically significant drug interactions occurring with the barbiturates have involved Phenobarbital (Pentalgin-N).

1. Anticoagulants: Phenobarbital (Pentalgin-N) lowers the plasma levels of dicumarol (name previously used: bishydorxycoumarin) and causes a decrease in anticoagulant activity as measured by the prothrombin time. Phenobarbital (Pentalgin-N) can induce hepatic microsomal enzymes resulting in increased metabolism and decreased anticoagulant response of oral anticoagulants (e.g., warfarin, acenocournarol, dicumarol, and phenprocoumon). Patients stabilized on anticoagulant therapy may require dosage adjustments if Phenobarbital (Pentalgin-N) is added to or withdrawn from their dosage regimen.

2. Corticosteroids: Phenobarbital (Pentalgin-N) appears to enhance the metabolism of exogenous corticosteroids probably through the induction of hepatic microsomal enzymes. Patients stabilized on corticosteroid therapy may require dosage adjustments if Phenobarbital (Pentalgin-N) is added to or withdrawn from their dosage regimen.

3. Griseofulvin: Phenobarbital (Pentalgin-N) appears to interfere with the absorption of orally administered griseofulvin, thus decreasing its blood level. The effect of the resultant decreased blood levels of griseofulvin on therapeutic response has not been established. However, it would be preferable to avoid concomitant administration of these drugs.

4. Doxycycline: Phenobarbital (Pentalgin-N) has been shown to shorten the half- life of doxycycline for as long as 2 weeks after barbiturate therapy is discontinued. This mechanism is probably through the induction of hepatic microsomal enzymes that metabolize the antibiotic. If Phenobarbital (Pentalgin-N) and doxycycline are administered concurrently, the clinical response to doxycycline should be monitored closely.

5. Phenytoin, sodium valproate, valproic acid: The effect of Phenobarbital (Pentalgin-N) on the metabolism of phenytoin appears to be variable. Some investigators report an accelerating effect, while others report no effect. Because the effect of Phenobarbital (Pentalgin-N) on the metabolism of phenytoin is not predictable, phenytoin and Phenobarbital (Pentalgin-N) blood levels should be monitored more frequently if these drugs are given concurrently. Sodium valproate and valproic acid appear to decrease Phenobarbital (Pentalgin-N) metabolism; therefore, Phenobarbital (Pentalgin-N) blood levels should be monitored and appropriate dosage adjustments made as indicated.

6. Central nervous system depressants: The concomitant use of other central nervous system depressants including other sedatives or hypnotics, antihistamines, tranquilizers, or alcohol, may produce additive depressant effects.

7. Monoamine oxidase inhibitors (MAOIs): MAOIs prolong the effects of Phenobarbital (Pentalgin-N) probably because metabolism of the Phenobarbital (Pentalgin-N) is inhibited.

8. Estradiol, estrone, progesterone and other steroidal hormones: Pretreatment with or concurrent administration of Phenobarbital (Pentalgin-N) may decrease the effect of estradiol by increasing its metabolism. There have been reports of patients treated with antiepileptic drugs (e.g., Phenobarbital (Pentalgin-N)) who became pregnant while taking oral contraceptives. An alternate contraceptive method might be suggested to women taking Phenobarbital (Pentalgin-N).

See also:
What are the possible side effects of Caffeine (Pentalgin-N)?

Overall, the reported number of adverse events in the double-blind period of the controlled trial was similar for the Caffeine (Pentalgin-N) and placebo groups. The following table shows adverse events that occurred in the double-blind period of the controlled trial and that were more frequent in Caffeine (Pentalgin-N) treated patients than placebo.

In addition to the cases above, three cases of necrotizing enterocolitis were diagnosed in patients receiving Caffeine (Pentalgin-N) during the open-label phase of the study.

Three of the infants who developed necrotizing enterocolitis during the trial died. All had been exposed to Caffeine (Pentalgin-N). Two were randomized to Caffeine (Pentalgin-N), and one placebo patient was “rescued” with open-label Caffeine (Pentalgin-N) for uncontrolled apnea.

Adverse events described in the published literature include: central nervous system stimulation (i.e., irritability, restlessness, jitteriness), cardiovascular effects (i.e., tachycardia, increased left ventricular output, and increased stroke volume), gastrointestinal effects (i.e., increased gastric aspirate, gastrointesti­nal intolerance), alterations in serum glucose (hypoglycemia and hyper­glycemia) and renal effects (increased urine flow rate, increased creatinine clearance, and increased sodium and calcium excretion). Published long-term follow-up studies have not shown Caffeine (Pentalgin-N) to adversely affect neurological development or growth parameters.

See also:
What are the possible side effects of Codeine (Pentalgin-N)?

Applies to Codeine (Pentalgin-N): oral solution, oral syrup, oral tablet, oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by Codeine (Pentalgin-N). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Codeine (Pentalgin-N):

Incidence not known:

• Bloating
• blurred vision
• chills
• cold, clammy skin
• confusion
• constipation
• darkened urine
• difficult or troubled breathing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• fast, weak pulse
• feeling of warmth
• fever
• indigestion
• irregular, fast or slow, or shallow breathing
• lightheadedness
• loss of appetite
• nausea
• no blood pressure or pulse
• no breathing
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale or blue lips, fingernails, or skin
• redness of the face, neck, arms, and occasionally, upper chest
• shortness of breath
• stopping of the heart
• sweating
• unconsciousness
• unusual tiredness or weakness
• vomiting
• wheezing
• yellow eyes or skin

If any of the following symptoms of overdose occur while taking Codeine (Pentalgin-N), get emergency help immediately:

Symptoms of overdose:

• Bluish lips or skin
• change in consciousness
• chest pain or discomfort
• constricted, pinpoint, or small pupils (black part of the eye)
• decreased awareness or responsiveness
• extreme sleepiness or unusual drowsiness
• loss of consciousness
• no blood pressure or pulse
• severe sleepiness
• slow or irregular heartbeat

Minor Side Effects

Some of the side effects that can occur with Codeine (Pentalgin-N) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

• Drowsiness
• relaxed and calm

• Abdominal or stomach pain or cramps
• blurred or loss of vision
• diarrhea
• disturbed color perception
• double vision
• dry mouth
• false or unusual sense of well-being
• fear or nervousness
• feeling of constant movement of self or surroundings
• halos around lights
• headache
• hives or welts
• itching skin
• night blindness
• overbright appearance of lights
• redness of the skin
• sensation of spinning
• shakiness
• skin rash
• sleeplessness
• trouble sleeping
• tunnel vision
• unable to sleep
• weight loss

May be nausea, vomiting, diarrhea or constipation, urticaria, hypersensitivity to the drug. Rarely granulocytopenia, epigastric pain, stomatitis. Regardless of the dose, Metamizole (Pentalgin-N) magnesium (Metamizole (Pentalgin-N)) can occasionally determine hypersensitivity, externalized, such as rash, leukopenia and rarely agranulocytosis, as well as fragments of impact or shock. Presented unfamiliar or unpleasant sensations impaired skin and mucous membranes, will need to stop and seek medical preparations.

If it had been observed previously and phenomena of intolerance to other analgesics or anti-flu preparations, consult your doctor before applying Metamizole (Pentalgin-N) magnesium (Metamizole (Pentalgin-N)). After intravenous injection, there may be dizziness, feeling of oppression and demonstrations by the CNS, without allergic genesis. After intravenous injection, there may be dizziness, feeling of oppression and demonstrations by the CNS, without allergic genesis. These side effects are largely avoided by slow injection (1 to 1.5 ml per minute). Rarely, injection Metamizole (Pentalgin-N) magnesium (Metamizole (Pentalgin-N)), depending on the dose may lead to hypotension, without hypersensitivity reactions.

See also:
What are the possible side effects of Naproxen (Pentalgin-N)?

Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis or osteoarthritis are listed below. In general, reactions in patients treated chronically were reported 2 to 10 times more frequently than they were in short-term studies in the 962 patients treated for mild to moderate pain or for dysmenorrhea. The most frequent complaints reported related to the gastrointestinal tract.

A clinical study found gastrointestinal reactions to be more frequent and more severe in rheumatoid arthritis patients taking daily doses of 1500 mg Naproxen (Pentalgin-N) compared to those taking 750 mg Naproxen (Pentalgin-N).

In controlled clinical trials with about 80 pediatric patients and in well-monitored, open-label studies with about 400 pediatric patients with juvenile arthritis treated with Naproxen (Pentalgin-N), the incidence of rash and prolonged bleeding times were increased, the incidence of gastrointestinal and central nervous system reactions were about the same, and the incidence of other reactions were lower in pediatric patients than in adults.

In patients taking Naproxen (Pentalgin-N) in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:

Gastrointestinal (GI) Experiences, including: heartburn*, abdominal pain*, nausea*, constipation*, diarrhea, dyspepsia, stomatitis

Central Nervous System: headache*, dizziness*, drowsiness*, lightheadedness, vertigo

Dermatologic: pruritus (itching)*, skin eruptions*, ecchymoses*, sweating, purpura

Special Senses: tinnitus*, visual disturbances, hearing disturbances

Cardiovascular: edema*, palpitations

General: dyspnea*, thirst

*Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients are unmarked.

In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients.

Gastrointestinal (GI) Experiences, including: flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting

General: abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes

The following are additional adverse experiences reported in <1% of patients taking Naproxen (Pentalgin-N) during clinical trials and through postmarketing reports. Those adverse reactions observed through postmarketing reports are italicized.

Body as a Whole: anaphylactoid reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever)

Cardiovascular: congestive heart failure, vasculitis, hypertension, pulmonary edema

Gastrointestinal: inflammation, bleeding (sometimes fatal, particularly in the elderly), ulceration, perforation and obstruction of the upper and lower gatrointestinal tract. Esophagitis, stomatitis, hematemesis, pancreatitis, vomiting, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn’s disease)

Hepatobiliary: jaundice, abnormal liver function tests, hepatitis (some causes have been fatal)

Hemic and Lymphatic: eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia

Metabolic and Nutritional: hyperglycemia, hypoglycemia

Nervous System: inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions

Respiratory: eosinophilic pneumonitis, asthma

Dermatologic: alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythema multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematoses, Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

Special Senses: hearing impairment, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema

Urogenital: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine

Reproduction (Female): infertility

In patients taking NSAIDs, the following adverse experiences have also been reported in <1% of patients.

Body as a Whole: fever, infection, sepsis, anaphylactic reactions, appetite changes, death

Cardiovascular: hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarction

Gastrointestinal: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, glossitis, eructation

Hepatobiliary: hepatitis, liver failure

Hemic and Lymphatic: rectal bleeding, lymphadenopathy, pancytopenia

Metabolic and Nutritional: weight changes

Nervous System: anxiety, asthenia, confusion, nervousness, paresthesia, somnolence, tremors, convulsions, coma, hallucinations

Respiratory: asthma, respiratory depression, pneumonia

Dermatologic: exfoliative dermatitis

Special Senses: blurred vision, conjunctivitis

Urogenital: cystitis, dysuria, oliguria/polyuria, proteinuri

See also:
What are the possible side effects of Phenobarbital (Pentalgin-N)?

The following adverse reactions and their incidence were compiled from surveillance of thousands of hospitalized patients.

• Nervous system: Somnolence.

• Nervous system: Agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality.
• Respiratory system: Hypoventilation, apnea.
• Cardiovascular system: Bradycardia, hypotension, syncope.
• Digestive system: Nausea, vomiting, constipation.
• Other reported reactions: Headache, injection site reactions, hypersensitivity reactions (angioedema skin rashes, exfoliative dermatitis), fever, liver damage, megaloblastic anemia following chronic Phenobarbital (Pentalgin-N) use.

DRUG ABUSE AND DEPENDENCE

Symptoms of acute intoxication with Phenobarbital (Pentalgin-N) include unsteady gait, slurred speech, and sustained nystagmus. Mental signs of chronic intoxication include confusion, poor judgment, irritability, insomnia, and somatic complaints.

Symptoms of Phenobarbital (Pentalgin-N) dependence are similar to those of chronic alcoholism. If an individual appears to be intoxicated with alcohol to a degree that is radically disproportionate to the amount of alcohol in his or her blood, the use of barbiturates should be suspected. The lethal dose of a barbiturate is far less if alcohol is also ingested. The symptoms of Phenobarbital (Pentalgin-N) withdrawal can be severe and may cause death. Minor withdrawal symptoms may appear 8 to 12 hours after the last dose of Phenobarbital (Pentalgin-N). These symptoms usually appear in the following order: anxiety, muscle twitching, tremor of hands and fingers, progressive weakness, dizziness, distortion in visual perception, nausea, vomiting, insomnia, and orthostatic hypotension. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of this drug. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Individuals susceptible to Phenobarbital (Pentalgin-N) abuse and dependence include alcoholics and opiate abusers, as well as other sedative- hypnotic and amphetamine abusers.

Drug dependence on Phenobarbital (Pentalgin-N) arises from repeated administration of the barbiturate or an agent with barbiturate- like effect on a continuous basis, generally in amounts exceeding therapeutic dose levels. The characteristics of drug dependence on Phenobarbital (Pentalgin-N) include: (a) a strong desire or need to continue taking the drug, (b) a tendency to increase the dose, (c) a psychic dependence on the effects of the drug related to subjective and individual appreciation of those effects, and (d) a physical dependence on the effects of the drug requiring its presence for maintenance of homeostasis and resulting in a definite, characteristic, and self-limited abstinence syndrome when the drug is withdrawn.

Treatment of Phenobarbital (Pentalgin-N) dependence consists of cautious and gradual withdrawal of the drug. One method involves substituting a 30 mg dose of Phenobarbital (Pentalgin-N) for each 100 to 200 mg dose that the patient has been taking. The total daily amount of Phenobarbital (Pentalgin-N) is then administered in 3 to 4 divided doses, not to exceed 600 mg daily. Should signs of withdrawal occur on the first day of treatment, a loading dose of 100 to 200 mg of Phenobarbital (Pentalgin-N) may be administered IM in addition to the oral dose. After stabilization on Phenobarbital (Pentalgin-N), the total daily dose is decreased by 30 mg a day as long as withdrawal is proceeding smoothly. A modification of this regimen involves initiating treatment at the patient's regular dosage level and decreasing the daily dosage by 10 percent if tolerated by the patient.

Infants physically dependent on Phenobarbital (Pentalgin-N) may be given a lower dose of Phenobarbital (Pentalgin-N) at 3 to 10 mg/kg/day. After withdrawal symptoms (hyperactivity, disturbed sleep, tremors, hyperreflexia) are relieved, the dosage of Phenobarbital (Pentalgin-N) should be gradually decreased and completely withdrawn over a 2-week period.

A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Caffeine (Pentalgin-N)'s most notable pharmacological effect is as a central nervous system stimulant, increasing alertness and producing agitation. It also relaxes smooth muscle, stimulates cardiac muscle, stimulates diuresis, and appears to be useful in the treatment of some types of headache. Several cellular actions of Caffeine (Pentalgin-N) have been observed, but it is not entirely clear how each contributes to its pharmacological profile. Among the most important are inhibition of cyclic nucleotide phosphodiesterases, antagonism of adenosine receptors, and modulation of intracellular calcium handling. [PubChem]

An opioid analgesic related to morphine but with less potent analgesic properties and mild sedative effects. It also acts centrally to suppress cough. [PubChem]

A thioureylene antithyroid agent that inhibits the formation of thyroid hormones by interfering with the incorporation of iodine into tyrosyl residues of thyroglobulin. This is done by interfering with the oxidation of iodide ion and iodotyrosyl groups through inhibition of the peroxidase enzyme.

Each tablet contains Naproxen (Pentalgin-N) 200 mg and sodium 20 mg. It also contains the following inactive ingredients: Povidone, microcrystalline cellulose, talc, magnesium stearate, purified water and Opadry (blue) in the coating. It is lactose- and gluten-free.

The sodium content of Naproxen (Pentalgin-N) is low, similar to a slice of wheat bread.

A barbiturate that is metabolized to Phenobarbital (Pentalgin-N). It has been used for similar purposes, especially in epilepsy, but there is no evidence mephobarbital offers any advantage over Phenobarbital (Pentalgin-N).