Doloflex Relax

Aluminium Hydroxide (Doloflex Relax) is an inorganic salt used as an antacid. It is a basic compound that acts by neutralizing hydrochloric acid in gastric secretions. Subsequent increases in pH may inhibit the action of pepsin. An increase in bicarbonate ions and prostaglandins may also confer cytoprotective effects.

A carbamate with hypnotic, sedative, and some muscle relaxant properties, although in therapeutic doses reduction of anxiety rather than a direct effect may be responsible for muscle relaxation. Carisoprodol (Doloflex Relax) has been reported to have anticonvulsant actions against petit mal seizures, but not against grand mal seizures (which may be exacerbated). It is used in the treatment of anxiety disorders, and also for the short-term management of insomnia but has largely been superseded by the benzodiazepines. (From Martindale, The Extra Pharmacopoeia, 30th ed, p603) Carisoprodol (Doloflex Relax) is a controlled substance in the U.S.

Each 100-g gel contains Ketoprofen (Doloflex Relax) [2-(3-benzoyl-phenyl)-propionic acid] 2.5 g and the following excipients: Carboxypolymethylene 2 g; ethyl alcohol 40 mL; esters of p-hydroxybenzoic acid 0.1 g; neroli oil 0.05 mL; lavender oil 0.1 mL; triethanolamine 1.35 g; distilled water qs.

Paracetamol (Doloflex Relax) is an organic compound that consists of a six-membered ring containing two opposing nitrogen atoms. Paracetamol (Doloflex Relax) 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 (Doloflex Relax). Their mode of Paracetamol (Doloflex Relax) is generally by paralysing parasites, which allows the host body to easily remove or expel the invading organism.

Aluminium Hydroxide (Doloflex Relax) is a vaccine which helps prevent hepatitis A and typhoid

fever. Hepatitis A is an infectious illness of the liver caused by a virus.

Typhoid fever is an infectious illness caused by a type of bacteria called

Salmonella typhi.

This vaccine should only be given to adults and teenagers aged 15

years and above.

Carisoprodol (Doloflex Relax) tablets, USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.

Carisoprodol (Doloflex Relax) tablets, USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see Dosage and Administration ( 2) ].

Carefully consider the potential benefits and risks of Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) and Ketoprofen (Doloflex Relax) and other treatment options before deciding to use Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) and Ketoprofen (Doloflex Relax). Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) and Ketoprofen (Doloflex Relax) are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

Ketoprofen (Doloflex Relax) is not recommended for treatment of acute pain because of its extended-release characteristics is indicated for the management of pain. Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) is also indicated for treatment of primary dysmenorrhea.

For systemic use of Paracetamol (Doloflex Relax) 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.

Aluminum is a naturally occurring mineral. Aluminium Hydroxide (Doloflex Relax) is an antacid.

Aluminium Hydroxide (Doloflex Relax) is used to treat symptoms of increased stomach acid, such as heartburn, upset stomach, sour stomach, or acid indigestion. Aluminium Hydroxide (Doloflex Relax) is also used to reduce phosphate levels in people with certain kidney conditions.

Aluminium Hydroxide (Doloflex Relax) may be used for other purposes not listed in this medication guide.

Carisoprodol (Doloflex Relax) is used to relax certain muscles in your body and relieve the discomfort caused by acute (short-term), painful muscle or bone conditions. However, Carisoprodol (Doloflex Relax) does not take the place of rest, exercise, physical therapy, or other treatments that your doctor may recommend for your medical condition.

Carisoprodol (Doloflex Relax) is a skeletal muscle relaxant. It acts on the central nervous system (CNS) to relax muscles.

Carisoprodol (Doloflex Relax) is available only with your doctor's prescription.

Ketoprofen (Doloflex Relax) is a nonsteroidal anti-inflammatory drug (NSAID). Ketoprofen (Doloflex Relax) works by reducing hormones that cause inflammation and pain in the body.

Ketoprofen (Doloflex Relax) is used to treat pain or inflammation caused by arthritis.

The Ketoprofen (Doloflex Relax) regular capsule is also used to treat mild to moderate pain, or menstrual pain.

Only Ketoprofen (Doloflex Relax) extended-release capsules are used for treating arthritis. This form of Ketoprofen (Doloflex Relax) will not work fast enough to treat acute pain.

Ketoprofen (Doloflex Relax) may also be used for purposes not listed in this medication guide.

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

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

Usual Adult Dose for Dyspepsia

500 to 600 mg orally 4 to 6 times a day as needed, between meals and at bedtime.

Usual Adult Dose for Duodenal Ulcer

500 to 1500 mg orally 4 to 6 times a day as needed, between meals and at bedtime.

Usual Adult Dose for Erosive Esophagitis

500 to 1500 mg orally 4 to 6 times a day as needed, between meals and at bedtime.

Usual Adult Dose for Gastric Ulcer

500 to 1500 mg orally 4 to 6 times a day as needed, between meals and at bedtime.

Usual Adult Dose for Gastroesophageal Reflux Disease

500 to 1500 mg orally 4 to 6 times a day as needed, between meals and at bedtime.

Usual Adult Dose for Zollinger-Ellison Syndrome

500 to 3600 mg orally 4 to 6 times a day as needed, between meals and at bedtime.

Usual Adult Dose for Hyperphosphatemia

500 to 1000 mg orally 4 times a day, with meals and at bedtime. The dosage should be titrated to the serum phosphate level.

Usual Pediatric Dose for Gastrointestinal Hemorrhage

G.I. hemorrhage prophylaxis:

0 to 4 weeks: 1 mL/kg orally every 4 hours as needed.

4 weeks to 1 year: 2 to 5 mL/dose every 1 to 2 hours, titrate to gastric pH > 3.5.

1 to 12 years: 5 to 15 mL/dose orally every 1 to 2 hours, titrate to gastric pH > 3.5.

Usual Pediatric Dose for Hyperphosphatemia

1 to 12 years: use Al(OH)3 or aluminum carbonate gel product only: 50 to 150 mg/kg/day orally (as Aluminium Hydroxide (Doloflex Relax) gel) administered in equally divided doses every 4 to 6 hours; titrate to normal serum phosphate level.

Usual Pediatric Dose for Peptic Ulcer

1 month to 1 year: 1 to 2 mL/kg/dose orally 1 to 3 hours after meals and at bedtime.

1 year to 12 years: 5 to 15 mL orally every 3 to 6 hours or 1 and 3 hours after meals and at bedtime.

Precautions

Patients with renal failure may accumulate aluminum with chronic use. Serum aluminum levels should be monitored or another antacid chosen.

Other Comments

Patients with Helicobacter pylori-associated ulcerative disease should be considered for anti-Helicobacter therapy (often bismuth salts, metronidazole and other antimicrobials).

Dosage Forms

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

Tablet,

Oral:

Carisoprodol (Doloflex Relax): 250 mg, 350 mg

Generic: 250 mg, 350 mg

Dosing: Adult

Musculoskeletal conditions:

Oral: 250 to 350 mg 3 times daily and at bedtime for a maximum recommended duration of 2 to 3 weeks.

Discontinuation in patients on long-term therapy: Although Carisoprodol (Doloflex Relax) should only be used for short periods (2 to 3 weeks), in patients with a history of long term use or high doses, Carisoprodol (Doloflex Relax) should be tapered off slowly (eg, over 14 days) to avoid withdrawal symptoms such as anxiety, insomnia, or irritability (Eleid 2010).

Dosing: Geriatric

Avoid use (Beers Criteria [AGS 2019]).

Dosing: Pediatric

Musculoskeletal conditions: Adolescents ≥16 years:

Oral: 250 to 350 mg 3 times daily and at bedtime (ie, 4 daily doses); maximum daily dose: 1,400 mg/day; maximum duration of therapy: 3 weeks

Discontinuation in patients on long-term therapy: Although Carisoprodol (Doloflex Relax) should only be used for short periods (2 to 3 weeks), experience in adult patients with a history of long-term use or high doses suggests Carisoprodol (Doloflex Relax) should be tapered off slowly (eg, over 14 days) to avoid withdrawal symptoms such as anxiety, insomnia, or irritability (Eleid 2010)

Carefully consider the potential benefits and risks of Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) and Ketoprofen (Doloflex Relax) and other treatment options before deciding to use Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) and Ketoprofen (Doloflex Relax). Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

After observing the response to initial therapy with Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) and Ketoprofen (Doloflex Relax), the dose and frequency should be adjusted to suit an individual patients needs.

Concomitant use of Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) and Ketoprofen (Doloflex Relax) is not recommended.

If minor side effects appear, they may disappear at a lower dose which may still have an adequate therapeutic effect. If well tolerated but not optimally effective, the dosage may be increased. Individual patients may show a better response to 300 mg of Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) daily as compared to 200 mg, although in well-controlled clinical trials patients on 300 mg did not show greater mean effectiveness. They did, however, show an increased frequency of upper- and lower-GI distress and headaches. It is of interest that women also had an increased frequency of these adverse effects compared to men. When treating patients with 300 mg/day, the physician should observe sufficient increased clinical benefit to offset potential increased risk.

In patients with mildly impaired renal function, the maximum recommended total daily dose of Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) or Ketoprofen (Doloflex Relax) is 150 mg. In patients with a more severe renal impairment (GFR less than 25 mL/min/1.73 m or end-stage renal impairment), the maximum total daily dose of Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) or Ketoprofen (Doloflex Relax) should not exceed 100 mg.

In elderly patients, renal function may be reduced with apparently normal serum creatinine and/or BUN levels. Therefore, it is recommended that the initial dosage of Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) or Ketoprofen (Doloflex Relax) should be reduced for patients over 75 years of age.

It is recommended that for patients with impaired liver function and serum albumin concentration less than 3.5 g/dL, the maximum initial total daily dose of Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) or Ketoprofen (Doloflex Relax) should be 100 mg. All patients with metabolic impairment, particularly those with both hypoalbuminemia and reduced renal function, may have increased levels of free (biologically active) Ketoprofen (Doloflex Relax) and should be closely monitored. The dosage may be increased to the range recommended for the general population, if necessary, only after good individual tolerance has been ascertained.

Because hypoalbuminemia and reduced renal function both increase the fraction of free drug (biologically active form), patients who have both conditions may be at greater risk of adverse effects. Therefore, it is recommended that such patients also be started on lower doses of Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) or Ketoprofen (Doloflex Relax) and closely monitored.

Rheumatoid Arthritis and Osteoarthritis

The recommended starting dose of Ketoprofen (Doloflex Relax) in otherwise healthy patients is for Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) 75 mg three times or 50 mg four times a day, or for Ketoprofen (Doloflex Relax) 200 mg administered once a day. Smaller doses of Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) or Ketoprofen (Doloflex Relax) should be utilized initially in small individuals or in debilitated or elderly patients. The recommended maximum daily dose of Ketoprofen (Doloflex Relax) is 300 mg/day for Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) or 200 mg/day for Ketoprofen (Doloflex Relax).

Dosages higher than 300 mg/day of Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) or 200 mg/day of Ketoprofen (Doloflex Relax) are not recommended because they have not been studied. Concomitant use of Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) and Ketoprofen (Doloflex Relax) is not recommended. Relatively smaller people may need smaller doses.

As with other nonsteroidal anti-inflammatory drugs, the predominant adverse effects of Ketoprofen (Doloflex Relax) are gastrointestinal. To attempt to minimize these effects, physicians may wish to prescribe that Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) or Ketoprofen (Doloflex Relax) be taken with antacids, food, or milk. Although food delays the absorption of both formulations, in most of the clinical trials Ketoprofen (Doloflex Relax) was taken with food or milk.

Physicians may want to make specific recommendations to patients about when they should take Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) or Ketoprofen (Doloflex Relax) in relation to food and/or what patients should do if they experience minor GI symptoms associated with either formulation.

Management of Pain and Dysmenorrhea

The usual dose of Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) recommended for mild-to-moderate pain and dysmenorrhea is 25 to 50 mg every 6 to 8 hours as necessary. A smaller dose should be utilized initially in small individuals, in debilitated or elderly patients, or in patients with renal or liver disease. A larger dose may be tried if the patients response to a previous dose was less than satisfactory, but doses above 75 mg have not been shown to give added analgesia. Daily doses above 300 mg are not recommended because they have not been adequately studied. Because of its typical nonsteroidal antiinflammatory drug-side-effect profile, including as its principal adverse effect GI side effects, higher doses of Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) should be used with caution and patients receiving them observed carefully.

Ketoprofen (Doloflex Relax) is not recommended for use in treating acute pain because of its extended-release characteristics.

How supplied

Ketoprofen (Doloflex Relax)® (Ketoprofen (Doloflex Relax)) Capsules are available as follows:

25 mg, NDC 0008-4186, dark-green and red capsule marked WYETH 4186 on one side and Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) 25 on the reverse side, in bottles of 100 capsules.

50 mg, NDC 0008-4181, dark-green and light-green capsule marked WYETH 4181 on one side and Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) 50 on the reverse side, in bottles of 100 capsules.

75 mg, NDC 0008-4187, dark-green and white capsule marked WYETH 4187 on one side and Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) 75 on the reverse side, in bottles of 100 and 500 capsules and in Redipak® cartons of 100 each containing 10 blister strips of 10 capsules.

Ketoprofen (Doloflex Relax)® (Ketoprofen (Doloflex Relax)) Extended-Release Capsules are available as follows:

100 mg, NDC 0008-0821, opaque pink and dark-green capsule marked with two radial bands and Ketoprofen (Doloflex Relax) 100 in bottles of 100 capsules.

150 mg, NDC 0008-0822, opaque pink and light-green capsule marked with two radial bands and Ketoprofen (Doloflex Relax) 150 in bottles of 100 capsules.

200 mg, NDC 0008-0690, opaque pink and off-white capsule marked with two radial bands and Ketoprofen (Doloflex Relax) 200 in bottles of 100 capsules and in Redipak® cartons each containing 10 blister strips of 10 capsules.

Keep tightly closed.

Store at room temperature, approximately 25° C (77° F).

Dispense in a tight container.

Ketoprofen (Doloflex Relax) capsules should be protected from direct light and excessive heat and humidity.

The appearance of these capsules is a registered trademark of Wyeth Pharmaceuticals.

By arrangement with Rhone-Poulenc Rorer France.

Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) Capsules manufactured and distributed by Wyeth Pharmaceuticals

Ketoprofen (Doloflex Relax) Capsules distributed by Wyeth Pharmaceuticals

Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101

Rev 07/05

FDA rev date: 01/18/06

Usual Adult Paracetamol (Doloflex Relax) 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 (Doloflex Relax) 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours

Usual Adult Paracetamol (Doloflex Relax) 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 (Doloflex Relax) 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.

See also:
What is the most important information I should know about Aluminium Hydroxide (Doloflex Relax)?

Aluminium Hydroxide (Doloflex Relax) should not be given if:

• you are allergic (hypersensitive) to Aluminium Hydroxide (Doloflex Relax) or any of the

ingredients (listed in Section 6)

• you are allergic (hypersensitive) to any other hepatitis A injection or

any other typhoid injection

• you are allergic to neomycin, an antibiotic used to treat skin infections

• you have a high temperature (fever).

Aluminium Hydroxide (Doloflex Relax) should not be given if any of the above applies to you. If you

are not sure, talk to your doctor or pharmacist before having Aluminium Hydroxide (Doloflex Relax).

See also:
What is the most important information I should know about Carisoprodol (Doloflex Relax)?

This medication may be habit-forming and should be used only by the person it was prescribed for. Carisoprodol (Doloflex Relax) should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

You may have withdrawal symptoms when you stop using Carisoprodol (Doloflex Relax) after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Carisoprodol (Doloflex Relax) can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase drowsiness and dizziness caused by Carisoprodol (Doloflex Relax).

See also:
What is the most important information I should know about Ketoprofen (Doloflex Relax)?

Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) and Ketoprofen (Doloflex Relax) are contraindicated in patients who have shown hypersensitivity to Ketoprofen (Doloflex Relax).

Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) and Ketoprofen (Doloflex Relax) should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic reactions to Ketoprofen (Doloflex Relax) have been reported in such patients.

Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) and Ketoprofen (Doloflex Relax) 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 Paracetamol (Doloflex Relax)?

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

Use Carisoprodol (Doloflex Relax) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Carisoprodol (Doloflex Relax) by mouth with or without food.
• If you miss a dose of Carisoprodol (Doloflex Relax) and you are taking it regularly, take it as soon as possible. If it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Carisoprodol (Doloflex Relax).

Use Ketoprofen (Doloflex Relax) extended-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Ketoprofen (Doloflex Relax) extended-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ketoprofen (Doloflex Relax) extended-release capsules refilled.
• Take Ketoprofen (Doloflex Relax) extended-release capsules 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.
• Swallow Ketoprofen (Doloflex Relax) extended-release capsules whole. Do not break, crush, or chew before swallowing.
• Take Ketoprofen (Doloflex Relax) extended-release capsules with a full glass of water (8 oz/240 mL) as directed by your doctor.
• If you miss a dose of Ketoprofen (Doloflex Relax) extended-release capsules 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 the proper use of Ketoprofen (Doloflex Relax) extended-release capsules.

Use Paracetamol (Doloflex Relax) 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 (Doloflex Relax) 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 (Doloflex Relax) could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking Paracetamol (Doloflex Relax) and never use more than 2 grams (2000 mg) per day. If you are treating a child, use a pediatric form of Paracetamol (Doloflex Relax). 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 (Doloflex Relax) 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 (Doloflex Relax) chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the Paracetamol (Doloflex Relax) 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 (Doloflex Relax) 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 (Doloflex Relax) 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 (Doloflex Relax) 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 (Doloflex Relax) 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 (Doloflex Relax). Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

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

Aluminium Hydroxide (Doloflex Relax) either alone or in combination with some other drugs is used to treat heartburn, upset or sour stomach, peptic ulcer and related pain, gastro esophageal reflux disease (GERD). It is also used in patients with kidney problems to reduce phosphate levels.

Carisoprodol (Doloflex Relax) is used short-term to treat muscle pain and discomfort. It is usually used along with rest, physical therapy, and other treatments. It works by helping to relax the muscles.

How to use Carisoprodol (Doloflex Relax)

Take this medication by mouth with or without food as directed by your doctor, usually 4 times a day.

The dosage is based on your medical condition and response to treatment. This medication should only be used short-term (for 3 weeks or less) unless directed by your doctor. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

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 stomach cramps, trouble sleeping, headache, nausea) may occur if you suddenly stop using this medication. 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.

Tell your doctor if your condition persists after 2 to 3 weeks or if it worsens.

Use: Labeled Indications

Osteoarthritis: Management of the signs and symptoms of osteoarthritis

Pain (immediate release only): Management of pain

Primary dysmenorrhea (immediate release only): Treatment of primary dysmenorrhea

Rheumatoid arthritis: Management of the signs and symptoms of rheumatoid arthritis

Off Label Uses

Ankylosing spondylitis

Data from a multicenter, randomized, double-blind, placebo- and active-comparator controlled trial supports the use of Ketoprofen (Doloflex Relax) in the treatment of ankylosing spondylitis.

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 (Doloflex Relax)

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.

See also:
What other drugs will affect Aluminium Hydroxide (Doloflex Relax)?

Using other medicines and vaccines

Please tell your doctor or pharmacist if you are taking or have recently

taken any other medicines including medicines obtained without

prescription. Aluminium Hydroxide (Doloflex Relax) can be given at the same time as most other

routine vaccines. The doctor will ensure that the vaccines are injected

separately and into different parts of the body. Aluminium Hydroxide (Doloflex Relax) must not be

mixed with other vaccines in the same syringe.

In particular talk to your doctor if:

• you are to be given ‘yellow fever vaccine

See also:
What other drugs will affect Carisoprodol (Doloflex Relax)?

CNS Depressants

The sedative effects of Carisoprodol (Doloflex Relax) and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously. Concomitant use of Carisoprodol (Doloflex Relax) and meprobamate, a metabolite of Carisoprodol (Doloflex Relax), is not recommended.

CYP2C19 Inhibitors and Inducers

Carisoprodol (Doloflex Relax) is metabolized in the liver by CYP2C19 to form meprobamate. Co-administration of CYP2C19 inhibitors, such as omeprazole or fluvoxamine, with Carisoprodol (Doloflex Relax) could result in increased exposure of Carisoprodol (Doloflex Relax) and decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampin or St. John's Wort, with Carisoprodol (Doloflex Relax) could result in decreased exposure of Carisoprodol (Doloflex Relax) and increased exposure of meprobamate. Low dose aspirin also showed an induction effect on CYP2C19. The full pharmacological impact of these potential alterations of exposures in terms of either efficacy or safety of Carisoprodol (Doloflex Relax) is unknown.

Drug Abuse And Dependence

Controlled Substance

Carisoprodol (Doloflex Relax) contains Carisoprodol (Doloflex Relax), a Schedule IV controlled substance. Carisoprodol (Doloflex Relax) has been subject to abuse, misuse, and criminal diversion for nontherapeutic use.

Abuse

Abuse of Carisoprodol (Doloflex Relax) poses a risk of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures and other disorders. Patients at high risk of Carisoprodol (Doloflex Relax) abuse may include those with prolonged use of Carisoprodol (Doloflex Relax), with a history of drug abuse, or those who use Carisoprodol (Doloflex Relax) in combination with other abused drugs.

Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological effects. Drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. Drug abuse and drug addiction are separate and distinct from physical dependence and tolerance (for example, abuse or addiction may not be accompanied by tolerance or physical dependence).

Dependence

Tolerance is when a patient's reaction to a specific dosage and concentration is progressively reduced in the absence of disease progression, requiring an increase in the dosage to maintain the same. Physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. Both tolerance and physical dependence have been reported with the prolonged use of Carisoprodol (Doloflex Relax). Reported withdrawal symptoms with Carisoprodol (Doloflex Relax) include insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, anxiety, ataxia, hallucinations, and psychosis. Instruct patients taking large doses of Carisoprodol (Doloflex Relax) or those taking the drug for a prolonged time to not abruptly stop Carisoprodol (Doloflex Relax).

See also:
What other drugs will affect Ketoprofen (Doloflex Relax)?

The following drug interactions were studied with Ketoprofen (Doloflex Relax) doses of 200 mg/day. The possibility of increased interaction should be kept in mind when Ketoprofen (Doloflex Relax) doses greater than 50 mg as a single dose or 200 mg of Ketoprofen (Doloflex Relax) per day are used concomitantly with highly bound drugs.

1. Antacids: Concomitant administration of magnesium hydroxide and Ketoprofen (Doloflex Relax) does not interfere with the rate or extent of the absorption of Ketoprofen (Doloflex Relax) administered as Ketoprofen (Doloflex Relax).

2. Aspirin: Ketoprofen (Doloflex Relax) does not alter aspirin absorption; however, in a study of 12 normal subjects, concurrent administration of aspirin decreased Ketoprofen (Doloflex Relax) protein binding and increased Ketoprofen (Doloflex Relax) plasma clearance from 0.07 L/kg/h without aspirin to 0.11 L/kg/h with aspirin. The clinical significance of these changes has not been adequately studied. Therefore, concurrent use of aspirin and Ketoprofen (Doloflex Relax) is not recommended.

3. Diuretic: Hydrochlorothiazide, given concomitantly with Ketoprofen (Doloflex Relax), produces a reduction in urinary potassium and chloride excretion compared to hydrochlorothiazide alone. Patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition.

4. Digoxin: In a study in 12 patients with congestive heart failure where Ketoprofen (Doloflex Relax) and digoxin were concomitantly administered, Ketoprofen (Doloflex Relax) did not alter the serum levels of digoxin.

5. Warfarin: In a short-term controlled study in 14 normal volunteers, Ketoprofen (Doloflex Relax) did not significantly interfere with the effect of warfarin on prothrombin time. Bleeding from a number of sites may be a complication of warfarin treatment and GI bleeding a complication of Ketoprofen (Doloflex Relax) treatment. Because prostaglandina play an important role in hemostasis and Ketoprofen (Doloflex Relax) has an effect on platelet function as well, concurent therapy with Ketoprofen (Doloflex Relax) and warfarin requires close monitoring of patients on both drugs.

6. Probenecid: Probenecid increases both free and bound Ketoprofen (Doloflex Relax) by reducing the plasma clearance of Ketoprofen (Doloflex Relax) to about one-third, as well as decreasing its protein binding. Therefore, the combination of Ketoprofen (Doloflex Relax) and probenecid is not recommended.

7. Methotrexate: Ketoprofen (Doloflex Relax), like other NSAIDs, may cause changes in the elimination of methotrexate leading to elevated serum levels of the drug and increased toxicity.

8. Lithium: Nonsteroidal anti-inflammatory agents have been reported to increase steadystate plasma lithium levels. It is recommended that plasma lithium levels be monitored when Ketoprofen (Doloflex Relax) is coadministered with lithium.

DRUG/LABORATORY TEST INTERACTIONS: EFFECT ON BLOOD COAGULATION

Ketoprofen (Doloflex Relax) decreases platelet adhesion and aggregation. Therefore, it can prolong bleeding time by approximately 3 to 4 minutes from baseline values. There is no significant change in platelet count, prothrombin time, partial thromboplastin time, or thrombin time.

See also:
What other drugs will affect Paracetamol (Doloflex Relax)?

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

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 (Doloflex Relax).

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

With the simultaneous use with urological means reduced their effectiveness.

With the simultaneous use of activated charcoal reduced bioavailability of Paracetamol (Doloflex Relax).

When Paracetamol (Doloflex Relax) 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 (Doloflex Relax). A case of severe toxic liver injury.

Described cases of toxic effects of Paracetamol (Doloflex Relax), while the use of isoniazid.

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

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

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

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

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

See also:
What are the possible side effects of Aluminium Hydroxide (Doloflex Relax)?

Applies to Aluminium Hydroxide (Doloflex Relax): oral suspension

Get emergency medical help if you have any of these signs of an allergic reaction while taking Aluminium Hydroxide (Doloflex Relax): hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using the medication and call your doctor at once if you have a serious side effect such as:

• severe stomach pain or constipation;

• bloody, black, or tarry stools;

• coughing up blood that looks like coffee grounds;

• pain when you urinate;

• extreme drowsiness; or

• tired feeling, loss of appetite, and muscle weakness.

Less serious side effects are more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

See also:
What are the possible side effects of Carisoprodol (Doloflex Relax)?

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice.

The data described below are based on 1387 patients pooled from two double blind, randomized, multicenter, placebo controlled, one-week trials in adult patients with acute, mechanical, lower back pain. In these studies, patients were treated with 250 mg of Carisoprodol (Doloflex Relax), 350 mg of Carisoprodol (Doloflex Relax), or placebo three times a day and at bedtime for seven days. The mean age was about 41 years old with 54% females and 46% males and 74 % Caucasian, 16 % Black, 9% Asian, and 2% other.

There were no deaths and there were no serious adverse reactions in these two trials. In these two studies, 2.7%, 2%, and 5.4%, of patients treated with placebo, 250 mg of Carisoprodol (Doloflex Relax), and 350 mg of Carisoprodol (Doloflex Relax), respectively, discontinued due to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of Carisoprodol (Doloflex Relax), and 350 mg of Carisoprodol (Doloflex Relax), respectively, discontinued due to central nervous system adverse reactions.

Table 1 displays adverse reactions reported with frequencies greater than 2% and more frequently than placebo in patients treated with Carisoprodol (Doloflex Relax) in the two trials described above.

Table 1: Patients with Adverse Reactions in Controlled Studies

Post-marketing Experience

The following events have been reported during postapproval use of Carisoprodol (Doloflex Relax). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: Tachycardia, postural hypotension, and facial flushing.

Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures.

Gastrointestinal: Nausea, vomiting, and epigastric discomfort.

Hematologic: Leukopenia, pancytopenia

See also:
What are the possible side effects of Ketoprofen (Doloflex Relax)?

The incidence of common adverse reactions (above 1%) was obtained from a population of 835 Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) -treated patients in double-blind trials lasting from 4 to 54 weeks and in 622 Ketoprofen (Doloflex Relax)-treated (200 mg/day) patients in trials lasting from 4 to 16 weeks.

Minor gastrointestinal side effects predominated; upper gastrointestinal symptoms were more common than lower gastrointestinal symptoms. In crossover trials in 321 patients with rheumatoid arthritis or osteoarthritis, there was no difference in either upper or lower gastrointestinal symptoms between patients treated with 200 mg of Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) once a day or 75 mg of Ketoprofen (Doloflex Relax) (Ketoprofen (Doloflex Relax)) TID (225 mg/day). Peptic ulcer or GI bleeding occurred in controlled clinical trials in less than 1% of 1,076 patients; however, in open label continuation studies in 1,292 patients the rate was greater than 2%.

The incidence of peptic ulceration in patients on NSAIDs is dependent on many risk factors including age, sex, smoking, alcohol use, diet, stress, concomitant drugs such as aspirin and corticosteroids, as well as the dose and duration of treatment with NSAIDs.

Gastrointestinal reactions were followed in frequency by central nervous system side effects, such as headache, dizziness, or drowsiness. The incidence of some adverse reactions appears to be dose-related. Rare adverse reactions (incidence less than 1%) were collected from one or more of the following sources: foreign reports to manufacturers and regulatory agencies, publications, U.S. clinical trials, and/or U.S. postmarketing spontaneous reports.

Reactions are listed below under body system, then by incidence or number of cases in decreasing incidence.

Incidence Greater than 1% (Probable Causal Relationship)

Digestive: Dyspepsia (11%), nausea*, abdominal pain*, diarrhea*, constipation*, flatulence*, anorexia, vomiting, stomatitis.

Nervous System: Headache*, dizziness, CNS inhibition (i.e., pooled reports of somnolence, malaise, depression, etc.) or excitation (i.e., insomnia, nervousness, dreams, etc.)*.

Special Senses: Tinnitus, visual disturbance.

Skin and Appendages: Rash.

Urogenital: Impairment of renal function (edema, increased BUN)*, signs or symptoms of urinary-tract irritation.

* Adverse events occurring in 3 to 9% of patients.

Incidence Less than 1% (Probable Causal Relationship)

Body as a Whole: Chills, facial edema, infection, pain, allergic reaction, anaphylaxis.

Cardiovascular: Hypertension, palpitation, tachycardia, congestive heart failure, peripheral vascular disease, vasodilation.

Digestive: Appetite increased, dry mouth, eructation, gastritis, rectal hemorrhage, melena, fecal occult blood, salivation, peptic ulcer, gastrointestinal perforation, hematemesis, intestinal ulceration, hepatic dysfunction, hepatitis, cholestatic hepatitis, jaundice.

Hemic: Hypocoagulability, agranulocytosis, anemia, hemolysis, purpura, thrombocytopenia.

Metabolic and Nutritional: Thirst, weight gain, weight loss, hyponatremia.

Musculoskeletal: Myalgia.

Nervous System: Amnesia, confusion, impotence, migraine, paresthesia, vertigo.

Respiratory: Dyspnea, hemoptysis, epistaxis, pharyngitis, rhinitis, bronchospasm, laryngeal edema.

Skin and Appendages: Alopecia, eczema, pruritus, purpuric rash, sweating, urticaria, bullous rash, exfoliative dermatitis, photosensitivity, skin discoloration, onycholysis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.

Special Senses: Conjunctivitis, conjunctivitis sicca, eye pain, hearing impairment, retinal hemorrhage and pigmentation change, taste perversion.

Urogenital: Menometrorrhagia, hematuria, renal failure, interstitial nephritis, nephrotic syndrome.

Incidence Less than 1% (Causal Relationship Unknown)

The following rare adverse reactions, whose causal relationship to Ketoprofen (Doloflex Relax) is uncertain, are being listed to serve as alerting information to the physician.

Body as a Whole: Septicemia, shock.

Cardiovascular: Arrhythmias, myocardial infarction.

Digestive: Buccal necrosis, ulcerative colitis, microvesicular steatosis, pancreatitis.

Endocrine: Diabetes mellitus (aggravated).

Nervous System: Dysphoria, hallucination, libido disturbance, nightmares, personality disorder, aseptic meningitis.

Urogenital: Acute tubulopathy, gynecomastia.

See also:
What are the possible side effects of Paracetamol (Doloflex Relax)?

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 (Doloflex Relax), side effects of aspirin 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 (Doloflex Relax).

At the doses and duration of recommended treatment, side effects are usually negligible, but the prolonged use of Paracetamol (Doloflex Relax) in therapeutic doses large (2-4 g per day, or 10-20 tablets Paracetamol (Doloflex Relax)) 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 (Doloflex Relax)) is described in paragraph overdose.