Codylex CC

Caffeine (Codylex CC) 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 (Codylex CC) and other analeptics should not be used in these conditions and recommend other supportive therapy.

Perennial Allergic Rhinitis: Cetirizine (Codylex CC) hydrochloride syrup is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.

Chronic Urticaria: Cetirizine (Codylex CC) hydrochloride syrup is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.

For systemic use of Paracetamol (Codylex CC) Sante Naturelle: prevention and treatment of hypo- and avitaminosis of vitamin C; providing increased need for vitamin C during growth, pregnancy, lactation, with heavy loads, fatigue and during recovery after prolonged severe illness; in winter with an increased risk of infectious diseases.

For intravaginal use: chronic or recurrent vaginitis (bacterial vaginosis, nonspecific vaginitis) caused by the anaerobic flora (due to changes in pH of the vagina) in order to normalize disturbed vaginal microflora.

Phenylephrine (Codylex CC) is used for the temporary relief of stuffy nose, sinus, and ear symptoms caused by the common cold, flu, allergies, or other breathing illnesses (e.g., sinusitis, bronchitis). This medication works by decreasing swelling in the nose and ears, thereby lessening discomfort and making it easier to breathe.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

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

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

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

Caffeine (Codylex CC) may also be used for other conditions as determined by your health care provider.

Cetirizine (Codylex CC) is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Cetirizine (Codylex CC) is used to treat cold or allergy symptoms such as sneezing, itching, watery eyes, or runny nose.

Cetirizine (Codylex CC) is also used to treat itching and swelling caused by chronic urticaria (hives).

Cetirizine (Codylex CC) may also be used for purposes not listed in this medication guide.

Paracetamol (Codylex CC) (acetaminophen) is a pain reliever and a fever reducer. The exact mechanism of Paracetamol (Codylex CC) of is not known.

Paracetamol (Codylex CC) is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers. It relieves pain in mild arthritis but has no effect on the underlying inflammation and swelling of the joint.

Paracetamol (Codylex CC) may also be used for other purposes not listed in this medication guide.

Phenylephrine (Codylex CC) ophthalmic causes constriction of blood vessels in the eyes. It also enlarges the pupils, reduces the production of fluid in the eyes, and increases the amount of fluid that drains from the eyes.

Phenylephrine (Codylex CC) ophthalmic available over-the-counter is used to relieve redness, burning, irritation, and dryness of the eye caused by wind, sun, and other minor irritants. Prescription-strength Phenylephrine (Codylex CC) ophthalmic is used to constrict blood vessels in the eye and to dilate (make bigger) the pupil for conditions such as glaucoma, before surgery, and before eye examinations.

Phenylephrine (Codylex CC) ophthalmic may also be used for purposes other than those 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 (Codylex CC) containing medications, foods, or beverages while taking this product because too much Caffeine (Codylex CC) 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 (Codylex CC) containing medications, foods, or beverages while taking this product because too much Caffeine (Codylex CC) 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 (Codylex CC), baseline serum levels of Caffeine (Codylex CC) should be measured in infants previously treated with theophylline, since preterm infants metabolize theophylline to Caffeine (Codylex CC). Likewise, baseline serum levels of Caffeine (Codylex CC) should be measured in infants born to mothers who consumed Caffeine (Codylex CC) prior to delivery, since Caffeine (Codylex CC) readily crosses the placenta.

Loading Dose: 20 mg/kg Caffeine (Codylex CC) intravenous (over 30 minutes) once

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

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

Serum concentrations of Caffeine (Codylex CC) 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 (Codylex CC).

Caffeine (Codylex CC) 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 (Codylex CC) for longer periods of treatment have not been established.

Usual Adult Dose for Allergic Rhinitis

5 to 10 mg orally or chewed once a day

Usual Adult Dose for Urticaria

5 to 10 mg orally or chewed once a day

Usual Pediatric Dose for Allergic Rhinitis

6 months to 2 years: 2.5 mg orally once a day, 12 months and older may be increased to 2.5 mg orally twice a day.

2 to 5 years: 2.5 mg orally once a day, may be increased to 5 mg/day in 1 to 2 divided doses.

6 years or older: 5 to 10 mg orally or chewed once a day.

Usual Pediatric Dose for Urticaria

6 months to 2 years: 2.5 mg orally once a day, 12 months and older may be increased to 2.5 mg orally twice a day.

2 to 5 years: 2.5 mg orally once a day, may be increased to 5 mg/day in 1 to 2 divided doses.

6 years or older: 5 to 10 mg orally or chewed once a day.

Renal Dose Adjustments

CrCl less than 30 mL/min: 5 mg orally or chewed once a day.

Use of Cetirizine (Codylex CC) is not recommended in children under 6 years of age with renal impairment due to the difficulty in reliably administering doses less than 2.5 mg (1/2 teaspoonful) and the lack of pharmacokinetic and safety information of Cetirizine (Codylex CC) in such patients.

Liver Dose Adjustments

5 mg orally or chewed once a day

Use of Cetirizine (Codylex CC) is not recommended in children under 6 years of age with hepatic impairment due to the difficulty in reliably administering doses less than 2.5 mg (1/2 teaspoonful) and the lack of pharmacokinetic and safety information of Cetirizine (Codylex CC) in such patients.

Precautions

In clinical trials, the occurrence of somnolence has been reported. Due caution should therefore be exercised when driving a car or operating potential dangerous machinery. Concurrent use of alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

Dialysis

Cetirizine (Codylex CC) is not significantly removed by hemodialysis, thus supplementary dosing is not required following hemodialysis. The recommended dosage for patients on hemodialysis is 5 mg orally or chewed once a day.

Usual Adult Paracetamol (Codylex CC) Dose for Fever:

General Dosing Guidelines: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours orally or rectally.

Paracetamol (Codylex CC) 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours

Usual Adult Paracetamol (Codylex CC) Dose for Pain:

General Dosing Guidelines: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours orally or rectally.

Paracetamol (Codylex CC) 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours

Usual Pediatric Dose for Fever:

Oral or Rectal:

<=1 month: 10 to 15 mg/kg/dose every 6 to 8 hours as needed.

>1 month to 12 years: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (Maximum: 5 doses in 24 hours)

Fever: 4 months to 9 years: Initial Dose: 30 mg/kg (Reported by one study (n=121) to be more effective in reducing fever than a 15 mg/kg maintenance dose with no difference regarding clinical tolerance.)

>=12 years: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours.

Usual Pediatric Dose for Pain:

Oral or Rectal:

<=1 month: 10 to 15 mg/kg/dose every 6 to 8 hours as needed.

>1 month to 12 years: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (Maximum: 5 doses in 24 hours)

Fever: 4 months to 9 years: Initial Dose: 30 mg/kg (Reported by one study (n=121) to be more effective in reducing fever than a 15 mg/kg maintenance dose with no difference regarding clinical tolerance.)

>=12 years: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours.

Prolonged exposure to air or strong light may cause oxidation and discoloration. Do not use if solution is brown or contains a precipitate.

Vasoconstriction and Pupil Dilatation

Phenylephrine (Codylex CC) (Phenylephrine (Codylex CC) hydrochloride ophthalmic solution) hydrochloride 10 percent ophthalmic solutions are especially useful when rapid and powerful dilatation of the pupil and reduction of congestion in the capillary bed are desired. A drop of a suitable topical anesthetic may be applied, followed in a few minutes by 1 drop of the Phenylephrine (Codylex CC) (Phenylephrine (Codylex CC) hydrochloride ophthalmic solution) hydrochloride 10 percent ophthalmic solutions on the upper limbus. The anesthetic prevents stinging and consequent dilution of the solution by lacrimation. It may occasionally be necessary to repeat the instillation after one hour, again preceded by the use of the topical anesthetic.

Uveitis: Posterior Synechiae

Phenylephrine (Codylex CC) (Phenylephrine (Codylex CC) hydrochloride ophthalmic solution) hydrochloride 10 percent ophthalmic solutions may be used in patients with uveitis when synechiae are present or may develop. The formation of synechiae may be prevented by the use of the 10 percent ophthalmic solutions and atropine to produce wide dilatation of the pupil. It should be emphasized, however, that the vasoconstrictor effect of Phenylephrine (Codylex CC) (Phenylephrine (Codylex CC) hydrochloride ophthalmic solution) hydrochloride may be antagonistic to the increase of local blood flow in uveal infection.

To free recently formed posterior synechiae, 1 drop of the 10 percent ophthalmic solutions may be applied to the upper surface of the cornea. On the following day, treatment may be continued if necessary. In the interim, hot compresses should be applied for five or ten minutes three times a day, with 1 drop of a 1 or 2 percent solution of atropine sulfate before and after each series of compresses.

Glaucoma

In certain patients with glaucoma, temporary reduction of intraocular tension may be attained by producing vasoconstriction of the intraocular vessels; this may be accomplished by placing 1 drop of the 10 percent ophthalmic solutions on the upper surface of the cornea. This treatment may be repeated as often as necessary.

Phenylephrine (Codylex CC) (Phenylephrine (Codylex CC) hydrochloride ophthalmic solution) hydrochloride may be used with miotics in patients with wide angle glaucoma. It reduces the difficulties experienced by the patient because of the small field produced by miosis, and still it permits and often supports the effect of the miotic in lowering the intraocular pressure. Hence, there may be marked improvement in visual acuity after using Phenylephrine (Codylex CC) (Phenylephrine (Codylex CC) hydrochloride ophthalmic solution) hydrochloride in conjunction with miotic drugs.

Surgery

When a short-acting mydriatic is needed for wide dilatation of the pupil before intraocular surgery, the 10 percent ophthalmic solutions or 2.5 percent ophthalmic solution may be applied topically from 30 to 60 minutes before the operation.

Refraction

Prior to determination of refractive errors, Phenylephrine (Codylex CC) (Phenylephrine (Codylex CC) hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution may be used effectively with homatropine hydrobromide, atropine sulfate, or a combination of homatropine and cocaine hydrochloride.

For adults, a drop of the preferred cycloplegic is placed in each eye, followed in five minutes by 1 drop of Phenylephrine (Codylex CC) (Phenylephrine (Codylex CC) hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution and in ten minutes by another drop of the cycloplegic. In 50 to 60 minutes, the eyes are ready for refraction.

For children, a drop of atropine sulfate 1 percent is placed in each eye, followed in 10 to 15 minutes by 1 drop of Phenylephrine (Codylex CC) (Phenylephrine (Codylex CC) hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution and in five to ten minutes by a second drop of atropine sulfate 1 percent. In one to two hours, the eyes are ready for refraction.

For a “one application method,” Phenylephrine (Codylex CC) (Phenylephrine (Codylex CC) hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution may be combined with a cycloplegic to elicit synergistic Phenylephrine (Codylex CC). The additive effect varies depending on the patient. Therefore, when using a “one application method,” it may be desirable to increase the concentration of the cycloplegic.

Ophthalmoscopic Examination

One drop of Phenylephrine (Codylex CC) (Phenylephrine (Codylex CC) hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution is placed in each eye. Sufficient mydriasis to permit examination is produced in 15 to 30 minutes. Dilatation lasts from one to three hours.

Diagnostic Procedures

Provocative Test for Angle Block in Patients with Glaucoma: The 2.5 percent ophthalmic solution may be used as a provocative test when latent increased intraocular pressure is suspected. Tension is measured before application of Phenylephrine (Codylex CC) (Phenylephrine (Codylex CC) hydrochloride ophthalmic solution) hydrochloride and again after dilatation. A 3 to 5 mm of mercury rise in pressure suggests the presence of angle block in patients with glaucoma; however, failure to obtain such a rise does not preclude the presence of glaucoma from other causes.

Shadow Test (Retinoscopy): When dilatation of the pupil without cycloplegic Phenylephrine (Codylex CC) is desired for the shadow test, the 2.5 percent ophthalmic solution may be used alone.

Blanching Test: One or 2 drops of the 2.5 percent ophthalmic solution should be applied to the injected eye. After five minutes, examine for perilimbal blanching. If blanching occurs, the congestion is superficial and probably does not indicate iritis.

How supplied

In Mono-Drop ® plastic dropper bottle: Low surface tension solutions

2.5 percent ophthalmic solution - Phenylephrine (Codylex CC) (Phenylephrine (Codylex CC) hydrochloride ophthalmic solution) hydrochloride 2.5 percent in a sterile, isotonic, buffered, low surface tension vehicle with sodium phosphate, sodium biphosphate, boric acid, and, as antiseptic preservative, benzalkonium chloride, NF, 1:7500. The pH is adjusted with phosphoric acid or sodium hydroxide. Bottles of 15 mL (NDC 0024-1358-01).

10 percent ophthalmic solution- Phenylephrine (Codylex CC) (Phenylephrine (Codylex CC) hydrochloride ophthalmic solution) hydrochloride 10 percent in a sterile, buffered, low surface tension vehicle with sodium phosphate, sodium biphosphate, and, as antiseptic preservative, benzalkonium chloride 1:10,000. The pH is adjusted with phosphoric acid or sodium hydroxide. Bottles of 5 mL (NDC 0024-1359-01).

Viscous solution

10 percent ophthalmic solution- Phenylephrine (Codylex CC) (Phenylephrine (Codylex CC) hydrochloride ophthalmic solution) hydrochloride 10 percent in a sterile, buffered, viscous vehicle with sodium phosphate, sodium biphosphate, methylcellulose, and, as antiseptic preservative, benzalkonium chloride 1:10,000. The pH is adjusted with phosphoric acid or sodium hydroxide. Bottles of 5 mL (NDC 0024-1362-01).

Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F)

Manufactured for Sanofi-Synthelabo Inc. New York, NY 10016 by Abbott Laboratories North Chicago, IL 60064. Revised September 1999. FDA revision date: n/a

See also:
What is the most important information I should know about Caffeine (Codylex CC)?

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

Before using Caffeine (Codylex CC), 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 (Codylex CC) 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 (Codylex CC).

To be sure Caffeine (Codylex CC) 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 Cetirizine (Codylex CC)?

Tablet: Cetirizine (Codylex CC) should not be used except under special circumstances for patients with hepatic and renal function impairment.

The risk-benefit should be considered when medical problems eg, bladder neck obstruction, prostatic hypertrophy, urinary retention and glaucoma exists.

Syrup: Hypersensitivity to Cetirizine (Codylex CC) dihydrochloride, hydroxyzine, any piperazine derivatives or to any of the excipients of Cetirizine (Codylex CC). Patients with severe renal impairment CrCl <10 mL/min. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Cetirizine (Codylex CC).

See also:
What is the most important information I should know about Paracetamol (Codylex CC)?

Paracetamol (Codylex CC) should not be used in patients who have previously exhibited hypersensitivity to Paracetamol (Codylex CC) and/or nonsteroidal antiinflammatory agents. Paracetamol (Codylex CC) should not be given to patients with a recent history of gastrointestinal bleeding or in patients with bleeding disorders (e.g., hemophilia).

See also:
What is the most important information I should know about Phenylephrine (Codylex CC)?

Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

If you wear contact lenses, remove them before applying Phenylephrine (Codylex CC) ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Phenylephrine (Codylex CC) ophthalmic may contains preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

Do not use Phenylephrine (Codylex CC) ophthalmic more often or continuously for longer than 48 to 72 hours without consulting a doctor. Chronic use of this medication may damage the blood vessels (veins and arteries) in the eyes. Consult a doctor if your symptoms do not improve or appear to worsen.

Use caution when driving, operating machinery, or performing other hazardous activities. Phenylephrine (Codylex CC) ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

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

Ask your health care provider any questions you may have about how to use Caffeine (Codylex CC).

Use Cetirizine (Codylex CC) orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Do not remove the blister unit from the carton until you are ready to take Cetirizine (Codylex CC) orally disintegrating tablets. Make sure that your hands are dry when you open the blister unit. Do not push the tablet through the foil. Peel back the foil on the blister unit and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Cetirizine (Codylex CC) orally disintegrating tablets may be taken with or without water. Take the tablet immediately after opening the blister unit. Do not store the removed tablet for future use.
• If you miss a dose of Cetirizine (Codylex CC) orally disintegrating 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 and 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 Cetirizine (Codylex CC) orally disintegrating tablets.

Use Paracetamol (Codylex CC) exactly as directed on the label, or as prescribed by your doctor.

Do not use more of this medication than is recommended. An overdose of Paracetamol (Codylex CC) can cause serious harm. The maximum amount for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Using more Paracetamol (Codylex CC) could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking Paracetamol (Codylex CC) and never use more than 2 grams (2000 mg) per day. If you are treating a child, use a pediatric form of Paracetamol (Codylex CC). Carefully follow the dosing directions on the medicine label. Do not give the medication to a child younger than 2 years old without the advice of a doctor.

Measure the liquid form of Paracetamol (Codylex CC) with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. You may need to shake the liquid before each use. Follow the directions on the medicine label.

The Paracetamol (Codylex CC) chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the Paracetamol (Codylex CC) disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the Paracetamol (Codylex CC) effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Do not take a Paracetamol (Codylex CC) rectal suppository by mouth. It is for use only in your rectum. Wash your hands before and after inserting the suppository.

Try to empty your bowel and bladder just before using the Paracetamol (Codylex CC) suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results from the suppository, lie down and insert the suppository pointed tip first into the rectum. Hold in the suppository for a few minutes. It will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after inserting the suppository.

Stop using Paracetamol (Codylex CC) and call your doctor if:

• you still have a fever after 3 days of use;

• you still have pain after 7 days of use (or 5 days if treating a child);

• you have a skin rash, ongoing headache, or any redness or swelling; or

• if your symptoms get worse, or if you have any new symptoms.

Urine glucose tests may produce false results while you are taking Paracetamol (Codylex CC). Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

Store Paracetamol (Codylex CC) at room temperature away from heat and moisture. The rectal suppositories can be stored at room temperature or in the refrigerator.

Use Phenylephrine (Codylex CC) drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Phenylephrine (Codylex CC) drops is for use in the eye only. Avoid contact with the nose or mouth.
• To use Phenylephrine (Codylex CC) drops, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including your eye. Keep the container tightly closed.
• Do not wear contact lenses while you are using Phenylephrine (Codylex CC) drops. Sterilize contact lenses according to the manufacturer's directions and check with your doctor before using them.
• Do not use Phenylephrine (Codylex CC) drops if it is brown or contains particles.
• If you miss a dose of Phenylephrine (Codylex CC) drops, 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 Phenylephrine (Codylex CC) drops.

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 (Codylex CC) 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 (Codylex CC) is suggested in patients with asymptomatic or symptomatic carotid artery atherosclerosis based on a slight reduction in total mortality observed when Caffeine (Codylex CC) 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 (Codylex CC) 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 (Codylex CC) in combination with clopidogrel was used for patients who underwent carotid artery stenting, which suggests that this antiplatelet combination is effective.

This combination medication is used to treat tension headaches. Acetaminophen helps to decrease the pain from the headache. Cetirizine (Codylex CC) helps increase the effects of acetaminophen. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat migraine headaches.

How to use Cetirizine (Codylex CC)

Take this medication by mouth with or without food as directed by your doctor, usually every 4 hours as needed.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition, age, and response to treatment. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.

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 nausea/vomiting, mental/mood changes, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. 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.

Tell your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Do not take more than recommended. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

How to use Paracetamol (Codylex CC)

Take this product by mouth as directed. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

There are many brands and forms of acetaminophen available. Read the dosing instructions carefully for each product because the amount of acetaminophen may be different between products. Do not take more acetaminophen than recommended.

If you are giving acetaminophen to a child, be sure you use a product that is meant for children. Use your child's weight to find the right dose on the product package. If you don't know your child's weight, you can use their age.

For suspensions, shake the medication well before each dose. Some liquids do not need to be shaken before use. Follow all directions on the product package. Measure the liquid medication with the provided dose-measuring spoon/dropper/syringe to make sure you have the correct dose. Do not use a household spoon.

For rapidly-dissolving tablets, chew or allow to dissolve on the tongue, then swallow with or without water. For chewable tablets, chew thoroughly before swallowing.

Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

For effervescent tablets, dissolve the dose in the recommended amount of water, then drink.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.

Do not take this medication for fever for more than 3 days unless directed by your doctor. For adults, do not take this product for pain for more than 10 days (5 days in children) unless directed by your doctor. If the child has a sore throat (especially with high fever, headache, or nausea/vomiting), consult the doctor promptly.

Tell your doctor if your condition persists or worsens or if you develop new symptoms. If you think you may have a serious medical problem, get medical help right away.

Use: Labeled Indications

Hypotension/shock: Treatment of hypotension, vascular failure in shock. Note: Not recommended for routine use in the treatment of septic shock; use should be limited until more evidence demonstrating positive clinical outcomes becomes available (Rhodes 2017).

Guideline recommendations:

Cardiogenic shock: The 2017 American Heart Association (AHA) scientific statement for the Contemporary Management of Cardiogenic Shock recommends Phenylephrine (Codylex CC), if needed, be considered for initial vasoactive management of cardiogenic shock due to aortic stenosis, mitral stenosis, or dynamic left ventricular outflow tract (LVOT) obstruction (AHA [van Diepen 2017]).

Hypotension during anesthesia: As a vasoconstrictor in regional analgesia

Nasal congestion: As a decongestant [OTC]

Off Label Uses

Hypotension in patients with obstructive hypertrophic cardiomyopathy

Phenylephrine (Codylex CC) is a pure alpha1 agonist that will increase systemic vascular resistance without increasing heart rate or contractility. This is advantageous in patients with obstructive hypertrophic cardiomyopathy and hypotension since increases in both heart rate and contractility may cause the obstruction to worsen, leading to a decrease in cardiac output. Other vasopressors like dopamine, epinephrine, and norepinephrine may increase contractility and/or heart rate. Additional trials may be necessary to further define the role of Phenylephrine (Codylex CC) in this condition.

Based on the American Urological Association guidelines for the management of priapism, due to the low risk of cardiovascular side effects intracavernous injection of Phenylephrine (Codylex CC) is recommended for ischemic priapism that persists following aspiration/irrigation.

See also:
What other drugs will affect Caffeine (Codylex CC)?

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

Adenosine: Caffeine (Codylex CC) and Caffeine (Codylex CC) Containing Products may diminish the therapeutic effect of Adenosine. Management: Monitor for decreased effect of adenosine if patient is receiving Caffeine (Codylex CC). Discontinue Caffeine (Codylex CC) 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 (Codylex CC) and Caffeine (Codylex CC) 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 (Codylex CC) and Caffeine (Codylex CC) Containing Products. Monitor therapy

CYP1A2 Inhibitors (Moderate): May increase the serum concentration of Caffeine (Codylex CC) and Caffeine (Codylex CC) Containing Products. Monitor therapy

CYP1A2 Inhibitors (Strong): May increase the serum concentration of Caffeine (Codylex CC) and Caffeine (Codylex CC) Containing Products. Monitor therapy

Doxofylline: Caffeine (Codylex CC) and Caffeine (Codylex CC) 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 (Codylex CC) and Caffeine (Codylex CC) Containing Products may enhance the adverse/toxic effect of Formoterol. Caffeine (Codylex CC) and Caffeine (Codylex CC) 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 (Codylex CC) and Caffeine (Codylex CC) Containing Products may enhance the adverse/toxic effect of Indacaterol. Caffeine (Codylex CC) and Caffeine (Codylex CC) 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 (Codylex CC) and Caffeine (Codylex CC) Containing Products may decrease the serum concentration of Lithium. Monitor therapy

Norfloxacin: May increase the serum concentration of Caffeine (Codylex CC) and Caffeine (Codylex CC) Containing Products. Monitor therapy

Olodaterol: Caffeine (Codylex CC) and Caffeine (Codylex CC) Containing Products may enhance the adverse/toxic effect of Olodaterol. Caffeine (Codylex CC) and Caffeine (Codylex CC) 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 (Codylex CC) and Caffeine (Codylex CC) Containing Products. Monitor therapy

Regadenoson: Caffeine (Codylex CC) and Caffeine (Codylex CC) Containing Products may diminish the vasodilatory effect of Regadenoson. Management: Avoiding using Caffeine (Codylex CC) 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 (Codylex CC) and Caffeine (Codylex CC) 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 (Codylex CC) and Caffeine (Codylex CC) Containing Products. Monitor therapy

See also:
What other drugs will affect Cetirizine (Codylex CC)?

Tablet: Concurrent use with alcohol may potentiate the CNS depressant effects of Cetirizine (Codylex CC); maprotiline or tricyclic antidepressants may potentiate the anticholinergic effects of either these medications or Cetirizine (Codylex CC).

Monoamine oxidase (MAO) inhibitors are not recommended because the use may prolong and intensify the anticholinergic and CNS depressant effects of Cetirizine (Codylex CC).

Concurrent use with ototoxic medications may mask the symptoms of ototoxicity eg, tinnitus, dizziness or vertigo; photosensitizing medications may cause additive photosensitizing effects.

Syrup: No interaction is observed for Cetirizine (Codylex CC) with pseudoephedrine, cimetidine, ketoconazole, erythromycin and azithromycin. Small decrease in Cetirizine (Codylex CC) clearance is observed when theophylline (400 mg once daily) is taken with Cetirizine (Codylex CC). However, disposition of theophylline was not altered by concomitant Cetirizine (Codylex CC) administration. Concomitant administration of Cetirizine (Codylex CC) and macrolides or ketoconazole has never resulted clinically relevant EGG changes. Extent of exposure to Cetirizine (Codylex CC) was increased by 40% when ritonavir is taken with Cetirizine (Codylex CC). Disposition of ritonavir was slightly altered further to concomitant Cetirizine (Codylex CC) administration.

See also:
What other drugs will affect Paracetamol (Codylex CC)?

With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic Paracetamol (Codylex CC) of Paracetamol (Codylex CC).

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 (Codylex CC).

With the simultaneous use of oral contraceptives accelerated excretion of Paracetamol (Codylex CC) from the body and may reduce its analgesic Paracetamol (Codylex CC).

With the simultaneous use with urological means reduced their effectiveness.

With the simultaneous use of activated charcoal reduced bioavailability of Paracetamol (Codylex CC).

When Paracetamol (Codylex CC) Guardian 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 (Codylex CC). A case of severe toxic liver injury.

Described cases of toxic effects of Paracetamol (Codylex CC), while the use of isoniazid.

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

In applying cholestyramine a period of less than 1 h after administration of Paracetamol (Codylex CC) 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 (Codylex CC) and its increased concentration in blood plasma.

When applied simultaneously with probenecid may decrease clearance of Paracetamol (Codylex CC), with rifampicin, sulfinpyrazone - may increase clearance of Paracetamol (Codylex CC) due to increasing its metabolism in the liver.

At simultaneous application of Paracetamol (Codylex CC) Guardian with ethinylestradiol increases absorption of Paracetamol (Codylex CC) from the gut.

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

See also:
What other drugs will affect Phenylephrine (Codylex CC)?

Acetaminophen: May increase the serum concentration of Phenylephrine (Codylex CC) (Systemic). Monitor therapy

Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1-Agonists may antagonize Alpha1-Blocker vasodilation. Monitor therapy

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

Benzylpenicilloyl Polylysine: Alpha1-Agonists may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Consider use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Consider therapy modification

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

Chloroprocaine: May enhance the hypertensive effect of Phenylephrine (Codylex CC) (Systemic). Monitor therapy

CloZAPine: May diminish the therapeutic effect of Phenylephrine (Codylex CC) (Systemic). 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

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Ergot Derivatives: May enhance the hypertensive effect of Alpha1-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha1-Agonists. Exceptions: Ergoloid Mesylates; Nicergoline. Avoid combination

FentaNYL: Alpha1-Agonists may decrease the serum concentration of FentaNYL. Specifically, fentanyl nasal spray serum concentrations may decrease and onset of effect may be delayed. Monitor therapy

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

Hyaluronidase: May enhance the vasoconstricting effect of Phenylephrine (Codylex CC) (Systemic). Management: Avoid the use of hyaluronidase to enhance dispersion or absorption of Phenylephrine (Codylex CC). Use of hyaluronidase for other purposes in patients receiving Phenylephrine (Codylex CC) may be considered as clinically indicated. Avoid combination

Iobenguane Radiopharmaceutical Products: Alpha1-Agonists may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Avoid combination

Ioflupane I 123: Phenylephrine (Codylex CC) (Systemic) may diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

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

Monoamine Oxidase Inhibitors: May enhance the hypertensive effect of Alpha1-Agonists. While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to linezolid specific monographs for details. Exceptions: Linezolid. Avoid combination

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

Propacetamol: May increase the serum concentration of Phenylephrine (Codylex CC) (Systemic). Management: Monitor patients closely for increased side effects of Phenylephrine (Codylex CC) if propacetamol is used concomitantly. Patients with underlying blood pressure issues or arrhythmias may need closer monitoring and may warrant consideration of alternative therapies. Monitor therapy

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

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

Tricyclic Antidepressants: May enhance the therapeutic effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the therapeutic effect of Alpha1-Agonists. Monitor therapy

See also:
What are the possible side effects of Caffeine (Codylex CC)?

Overall, the reported number of adverse events in the double-blind period of the controlled trial was similar for the Caffeine (Codylex CC) 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 (Codylex CC) treated patients than placebo.

In addition to the cases above, three cases of necrotizing enterocolitis were diagnosed in patients receiving Caffeine (Codylex CC) 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 (Codylex CC). Two were randomized to Caffeine (Codylex CC), and one placebo patient was “rescued” with open-label Caffeine (Codylex CC) 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 (Codylex CC) to adversely affect neurological development or growth parameters.

See also:
What are the possible side effects of Cetirizine (Codylex CC)?

Pediatric studies were conducted with Cetirizine (Codylex CC) hydrochloride. More than 1300 pediatric patients aged 6 to 11 years with more than 900 treated with Cetirizine (Codylex CC) hydrochloride at doses of 1.25 to 10 mg per day were included in controlled and uncontrolled clinical trials conducted in the United States. The duration of treatment ranged from 2 to 12 weeks. Placebo-controlled trials up to 4 weeks duration included 168 pediatric patients aged 2 to 5 years who received Cetirizine (Codylex CC), the majority of whom received single daily doses of 5 mg. A placebo-controlled trial 18 months in duration included 399 patients aged 12 to 24 months treated with Cetirizine (Codylex CC) (0.25 mg/kg bid), and another placebo-controlled trial of 7 days duration included 42 patients aged 6 to 11 months who were treated with Cetirizine (Codylex CC) (0.25 mg/kg bid).

The majority of adverse reactions reported in pediatric patients aged 2 to 11 years with Cetirizine (Codylex CC) hydrochloride were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in pediatric patients receiving up to 10 mg of Cetirizine (Codylex CC) hydrochloride was uncommon (0.4% on Cetirizine (Codylex CC) hydrochloride vs. 1.0% on placebo).

Table 1 lists adverse experiences which were reported for Cetirizine (Codylex CC) hydrochloride 5 and 10 mg in pediatric patients aged 6 to 11 years in placebo-controlled clinical trials in the United States and were more common with Cetirizine (Codylex CC) hydrochloride than placebo. Of these, abdominal pain was considered treatment-related and somnolence appeared to be dose-related, 1.3% in placebo, 1.9% at 5 mg and 4.2% at 10 mg. The adverse experiences reported in pediatric patients aged 2 to 5 years in placebo-controlled trials were qualitatively similar in nature and generally similar in frequency to those reported in trials with children aged 6 to 11 years.

In the placebo-controlled trials of pediatric patients 6 to 24 months of age, the incidences of adverse experiences, were similar in the Cetirizine (Codylex CC) and placebo treatment groups in each study. Somnolence occurred with essentially the same frequency in patients who received Cetirizine (Codylex CC) hydrochloride and patients who received placebo. In a study of 1 week duration in children 6 to 11 months of age, patients who received Cetirizine (Codylex CC) exhibited greater irritability/fussiness than patients on placebo. In a study of 18 months duration in patients 12 months and older, insomnia occurred more frequently in patients who received Cetirizine (Codylex CC) compared to patients who received placebo (9.0% v. 5.3%). In those patients who received 5 mg or more per day of Cetirizine (Codylex CC) as compared to patients who received placebo, fatigue (3.6% v. 1.3%) and malaise (3.6% v. 1.8%) occurred more frequently.

Table 1.

Adverse Experiences Reported in Pediatric Patients Aged 6 to 11 Years in Placebo-Controlled United States Cetirizine (Codylex CC) Hydrochloride Trials (5 or 10 mg Dose) Which Occurred at a Frequency of ≥2% in Either the 5-mg or the 10-mg Cetirizine (Codylex CC) Hydrochloride Group, and More Frequently Than in the Placebo Group

The following events were observed infrequently (less than 2%), in either 3982 adults and children 12 years and older or in 659 pediatric patients aged 6 to 11 years who received Cetirizine (Codylex CC) hydrochloride in U.S. trials, including an open adult study of six months duration. A causal relationship of these infrequent events with Cetirizine (Codylex CC) hydrochloride administration has not been established.

Autonomic Nervous System: anorexia, flushing, increased salivation, urinary retention.

Cardiovascular: cardiac failure, hypertension, palpitation, tachycardia.

Central and Peripheral Nervous Systems: abnormal coordination, ataxia, confusion, dysphonia, hyperesthesia, hyperkinesia, hypertonia, hypoesthesia, leg cramps, migraine,

myelitis, paralysis, paresthesia, ptosis, syncope, tremor, twitching, vertigo, visual field defect.

Gastrointestinal: abnormal hepatic function, aggravated tooth caries, constipation, dyspepsia, eructation, flatulence, gastritis, hemorrhoids, increased appetite, melena, rectal hemorrhage, stomatitis including ulcerative stomatitis, tongue discoloration, tongue edema.

Genitourinary: cystitis, dysuria, hematuria, micturition frequency, polyuria, urinary incontinence, urinary tract infection.

Hearing and Vestibular: deafness, earache, ototoxicity, tinnitus.

Metabolic/Nutritional: dehydration, diabetes mellitus, thirst.

Musculoskeletal: arthralgia, arthritis, arthrosis, muscle weakness, myalgia.

Psychiatric: abnormal thinking, agitation, amnesia, anxiety, decreased libido, depersonalization, depression, emotional lability, euphoria, impaired concentration, insomnia, nervousness, paroniria, sleep disorder.

Respiratory System: bronchitis, dyspnea, hyperventilation, increased sputum, pneumonia, respiratory disorder, rhinitis, sinusitis, upper respiratory tract infection.

Reproductive: dysmenorrhea, female breast pain, intermenstrual bleeding, leukorrhea, menorrhagia, vaginitis.

Reticuloendothelial: lymphadenopathy.

Skin: acne, alopecia, angioedema, bullous eruption, dermatitis, dry skin, eczema, erythematous rash, furunculosis, hyperkeratosis, hypertrichosis, increased sweating, maculopapular rash, photosensitivity reaction, photosensitivity toxic reaction, pruritus, purpura, rash, seborrhea, skin disorder, skin nodule, urticaria.

Special Senses: parosmia, taste loss, taste perversion.

Vision: blindness, conjunctivitis, eye pain, glaucoma, loss of accommodation, ocular hemorrhage, xerophthalmia.

Body as a Whole: accidental injury, asthenia, back pain, chest pain, enlarged abdomen, face edema, fever, generalized edema, hot flashes, increased weight, leg edema, malaise, nasal polyp, pain, pallor, periorbital edema, peripheral edema, rigors.

Occasional instances of transient, reversible hepatic transaminase elevations have occurred during Cetirizine (Codylex CC) therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of Cetirizine (Codylex CC) hydrochloride has been reported.

Post-Marketing Experience

In the post-marketing experience period, the following additional rare, but potentially severe adverse events have been reported: aggressive reaction, anaphylaxis, cholestasis, convulsions, glomerulonephritis, hallucinations, hemolytic anemia, hepatitis, orofacial dyskinesia, severe hypotension, stillbirth, suicidal ideation, suicide and thrombocytopenia.

See also:
What are the possible side effects of Paracetamol (Codylex CC)?

Effects due to the presence of acetylsalicylic acid.

Accidents awareness with respiratory or skin reactions (angioedema, urticaria, asthma, anaphylactic shock);

Cross hypersensitivity reactions with NSAIDs and with tartrazine;

At low doses recommended for the use of Paracetamol (Codylex CC), side effects of Paracetamol (Codylex CC) are generally limited to some irritation of the gastro-intestinal tract.

At higher doses, side effects include gastrointestinal mucosal erosions, gastric ulcer or duodenal ulcer, occult blood loss, melena.

Acetylsalicylic acid may also increase the tendency to bleeding and bleeding time (the lengthening of bleeding continues 4-6 days after stopping the drug).

It may also worsen renal function including cases of pre-existing condition (the long-term use can cause chronic kidney disease).

The signs of salicylic overdose described under.

Effects due to the presence of Paracetamol (Codylex CC).

At the doses and duration of recommended treatment, side effects are usually negligible, but the prolonged use of Paracetamol (Codylex CC) in therapeutic doses large (2-4 g per day, or 10-20 tablets Paracetamol (Codylex CC)) may cause the appearance chronic hepatitis. This justifies the recommendations of caution especially in patients with liver disease prior.

Very rarely, it can produce thrombocytopenia.

The acute liver toxicity in overdose massive (doses greater than 8 g of Paracetamol (Codylex CC)) is described in paragraph overdose.

See also:
What are the possible side effects of Phenylephrine (Codylex CC)?

Applies to Phenylephrine (Codylex CC): intravenous solution

In addition to its needed effects, some unwanted effects may be caused by Phenylephrine (Codylex CC) (the active ingredient contained in Phenylephrine (Codylex CC)). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking Phenylephrine (Codylex CC), check with your doctor or nurse immediately:

Incidence not known:

• Blurred vision
• chest pain or discomfort
• difficult or labored breathing
• dizziness
• fainting
• fast, slow, or irregular heartbeat
• headache
• nausea or vomiting
• nervousness
• pain in the shoulders, arms, jaw, or neck
• pounding in the ears
• sweating
• tightness in the chest
• unusual tiredness

If any of the following symptoms of overdose occur while taking Phenylephrine (Codylex CC), get emergency help immediately:

Symptoms of overdose:

• Feeling of fullness in the head
• pounding or rapid pulse
• tingling in the arms or legs
• vomiting

Minor Side Effects

Some of the side effects that can occur with Phenylephrine (Codylex CC) 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:

Incidence not known:

• Heartburn
• itching skin
• nausea
• pain in the neck
• pain or discomfort in chest, upper stomach, or throat

A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Caffeine (Codylex CC)'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 (Codylex CC) 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]

Cetirizine (Codylex CC) HCl is a piperazine derivative and a metabolite of hydroxyzine. It competes reversibly with histamine to block the histamine (H₁) receptor sites. Cetirizine (Codylex CC) HCl is considered a long-acting nonsedating antihistamine and has some mast-cell stabilizing activity.

Paracetamol (Codylex CC) is an organic compound that consists of a six-membered ring containing two opposing nitrogen atoms. Paracetamol (Codylex CC) exists as small alkaline deliquescent crystals with a saline tasteacinol was introduced to medicine as a solvent for uric acid. When taken into the body the drug is partly oxidized and partly eliminated unchanged. Outside the body, piperazine has a remarkable power to dissolve uric acid and producing a soluble urate, but in clinical experience it has not proved equally successfulacinol was first introduced as an anthelmintic in 1953. A large number of piperazine compounds have anthelmintic Paracetamol (Codylex CC). Their mode of Paracetamol (Codylex CC) is generally by paralysing parasites, which allows the host body to easily remove or expel the invading organism.

Phenylephrine (Codylex CC) is a sympathomimetic amine that acts predominantly on α-adrenergic receptors. It is mainly used to treat nasal congestion, but may also be useful in treating hypotension and shock, hypotension during spinal anaesthesia, prolongation of spinal anaesthesia, paroxysmal supraventricular tachycardia, symptomatic relief of external or internal hemorrhoids, and to increase blood pressure as an aid in the diagnosis of heart murmurs.