Reumophan Vit

A centrally acting central muscle relaxant with sedative properties. It is claimed to inhibit muscle spasm by exerting an effect primarily at the level of the spinal cord and subcortical areas of the brain. (From Martindale, The Extra Pharmacopoea, 30th ed, p1202)

Each 100-g gel contains Ketoprofen (Reumophan Vit) [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.

Pyridoxine (Reumophan Vit) is the 4-methanol form of Pyridoxine (Reumophan Vit) and is converted to pyridoxal 5-phosphate in the body. Pyridoxal 5-phosphate is a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. Although Pyridoxine (Reumophan Vit) and Pyridoxine (Reumophan Vit) are still frequently used as synonyms, especially by medical researchers, this practice is erroneous and sometimes misleading. [PubChem]

Thiamine (Reumophan Vit) or thiamin, also known as Thiamine (Reumophan Vit), is a colorless compound with the chemical formula C12H17N4OS. It is soluble in water and insoluble in alcohol. Thiamine (Reumophan Vit) decomposes if heated. Thiamine (Reumophan Vit) was first discovered by Umetaro Suzuki in Japan when researching how rice bran cured patients of Beriberi. Thiamine (Reumophan Vit) plays a key role in intracellular glucose metabolism and it is thought that Thiamine (Reumophan Vit) inhibits the effect of glucose and insulin on arterial smooth muscle cell proliferation. Thiamine (Reumophan Vit) plays an important role in helping the body convert carbohydrates and fat into energy. It is essential for normal growth and development and helps to maintain proper functioning of the heart and the nervous and digestive systems. Thiamine (Reumophan Vit) cannot be stored in the body; however, once absorbed, the vitamin is concentrated in muscle tissue.

Chlorzoxazone (Reumophan Vit) is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone (Reumophan Vit) does not directly relax tense skeletal muscles in man.

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

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

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

Pyridoxine (Reumophan Vit) Hydrochloride Injection is effective for the treatment of Pyridoxine (Reumophan Vit) deficiency as seen in the following:

Inadequate dietary intake.

Drug-induced deficiency, as from isoniazid (INH) or oral contraceptives.

Inborn errors of metabolism, e.g., Pyridoxine (Reumophan Vit) dependent convulsions or Pyridoxine (Reumophan Vit) responsive anemia.

The parenteral route is indicated when oral administration is not feasible as in anorexia, nausea and vomiting, and preoperative and postoperative conditions. It is also indicated when gastrointestinal absorption is impaired.

Thiamine (Reumophan Vit) Hydrochloride Injection is effective for the treatment of Thiamine (Reumophan Vit) deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine (Reumophan Vit) Hydrochloride Injection should be used where rapid restoration of Thiamine (Reumophan Vit) is necessary, as in Wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to Thiamine (Reumophan Vit) deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal Thiamine (Reumophan Vit) status to avoid precipitation of heart failure.

Thiamine (Reumophan Vit) Hydrochloride Injection is also indicated in patients with established Thiamine (Reumophan Vit) deficiency who cannot take Thiamine (Reumophan Vit) orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine (Reumophan Vit) Hydrochloride Injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given.

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

Chlorzoxazone (Reumophan Vit) is a skeletal muscle relaxant. It acts on the central nervous system (CNS) to relax muscles.

Chlorzoxazone (Reumophan Vit) is available only with your doctor's prescription.

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

Ketoprofen (Reumophan Vit) is used to treat pain or inflammation caused by arthritis.

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

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

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

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Pyridoxine (Reumophan Vit) (vitamin B 6) is necessary for normal breakdown of proteins, carbohydrates, and fats.

Some conditions may increase your need for Pyridoxine (Reumophan Vit). These include:

• Alcoholism
• Burns
• Diarrhea
• Dialysis
• Heart disease
• Intestinal problems
• Liver disease
• Overactive thyroid
• Stress, long-term illness, or serious injury
• Surgical removal of stomach

In addition, infants receiving unfortified formulas such as evaporated milk may need additional Pyridoxine (Reumophan Vit).

Increased need for Pyridoxine (Reumophan Vit) should be determined by your health care professional.

Lack of Pyridoxine (Reumophan Vit) may lead to anemia (weak blood), nerve damage, seizures, skin problems, and sores in the mouth. Your doctor may treat these problems by prescribing Pyridoxine (Reumophan Vit) for you.

Claims that Pyridoxine (Reumophan Vit) is effective for treatment of acne and other skin problems, alcohol intoxication, asthma, hemorrhoids, kidney stones, mental problems, migraine headaches, morning sickness, and menstrual problems, or to stimulate appetite or milk production have not been proven.

Injectable Pyridoxine (Reumophan Vit) is given by or under the supervision of a health care professional. Other forms of Pyridoxine (Reumophan Vit) are available without a prescription.

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Thiamine (Reumophan Vit) (vitamin B 1) is needed for the breakdown of carbohydrates.

Some conditions may increase your need for Thiamine (Reumophan Vit). These include:

• Alcoholism
• Burns
• Diarrhea (continuing)
• Fever (continuing)
• Illness (continuing)
• Intestinal disease
• Liver disease
• Overactive thyroid
• Stress (continuing)
• Surgical removal of stomach

Also, the following groups of people may have a deficiency of Thiamine (Reumophan Vit):

• Patients using an artificial kidney (on hemodialysis)
• Individuals who do heavy manual labor on a daily basis

Increased need for Thiamine (Reumophan Vit) should be determined by your health care professional.

Lack of Thiamine (Reumophan Vit) may lead to a condition called beriberi. Signs of beriberi include loss of appetite, constipation, muscle weakness, pain or tingling in arms or legs, and possible swelling of feet or lower legs. In addition, if severe, lack of Thiamine (Reumophan Vit) may cause mental depression, memory problems, weakness, shortness of breath, and fast heartbeat. Your health care professional may treat this by prescribing Thiamine (Reumophan Vit) for you.

Thiamine (Reumophan Vit) may also be used for other conditions as determined by your health care professional.

Claims that Thiamine (Reumophan Vit) is effective for treatment of skin problems, chronic diarrhea, tiredness, mental problems, multiple sclerosis, nerve problems, and ulcerative colitis (a disease of the intestines), or as an insect repellant or to stimulate appetite have not been proven.

Injectable Thiamine (Reumophan Vit) is administered only by or under the supervision of your health care professional. Other forms of Thiamine (Reumophan Vit) are available without a prescription.

Once a medicine or dietary supplement has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, Thiamine (Reumophan Vit) is used in certain patients with the following medical conditions:

• Enzyme deficiency diseases such as encephalomyelopathy, maple syrup urine disease, pyruvate carboxylase, and hyperalaninemia

Usual Adult Dosage

Chlorzoxazone (Reumophan Vit)® Tablets (Chlorzoxazone (Reumophan Vit) USP) 375 mg

One tablet three or four times daily. If adequate response is not obtained with this dose, the 375 mg tablets may be increased to two tablets (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced.

Chlorzoxazone (Reumophan Vit)® Tablets (Chlorzoxazone (Reumophan Vit) USP) 750 mg

1/3 tablet (250 mg) three or four times daily. Initial dosage for painful musculoskeletal condition should be 2/3 tablet (500 mg) three to four times daily. If adequate response is not obtained with this dose, it may be increased to one tablet (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced.

How supplied

Chlorzoxazone (Reumophan Vit)® Tablets (Chlorzoxazone (Reumophan Vit) USP) are supplied as follows:

375 mg

A white capsule shaped tablet, debossed “ADG” on one side and “375” on the other side, in bottles of 100 tablets, NDC 68025-046-10.

750 mg

A white capsule shaped tablet, debossed “ADG” on the trisected side and “750” on the bisected side, in bottles of 100 tablets, NDC 68025-047-10.

Dispense in a tight container as defined in the official compendium.

Store at 20° to 25° C (68° to 77° F).

Manufactured for: Vertical Pharmaceuticals, LLC, Sayreville, NJ 08872. Revised: 2014

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

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

Concomitant use of Ketoprofen (Reumophan Vit) (Ketoprofen (Reumophan Vit)) and Ketoprofen (Reumophan Vit) 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 (Reumophan Vit) (Ketoprofen (Reumophan Vit)) 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 (Reumophan Vit) (Ketoprofen (Reumophan Vit)) or Ketoprofen (Reumophan Vit) 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 (Reumophan Vit) (Ketoprofen (Reumophan Vit)) or Ketoprofen (Reumophan Vit) 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 (Reumophan Vit) (Ketoprofen (Reumophan Vit)) or Ketoprofen (Reumophan Vit) 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 (Reumophan Vit) (Ketoprofen (Reumophan Vit)) or Ketoprofen (Reumophan Vit) 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 (Reumophan Vit) 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 (Reumophan Vit) (Ketoprofen (Reumophan Vit)) or Ketoprofen (Reumophan Vit) and closely monitored.

Rheumatoid Arthritis and Osteoarthritis

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

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

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

Physicians may want to make specific recommendations to patients about when they should take Ketoprofen (Reumophan Vit) (Ketoprofen (Reumophan Vit)) or Ketoprofen (Reumophan Vit) 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 (Reumophan Vit) (Ketoprofen (Reumophan Vit)) 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 (Reumophan Vit) (Ketoprofen (Reumophan Vit)) should be used with caution and patients receiving them observed carefully.

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

How supplied

Ketoprofen (Reumophan Vit)® (Ketoprofen (Reumophan Vit)) Capsules are available as follows:

25 mg, NDC 0008-4186, dark-green and red capsule marked WYETH 4186 on one side and Ketoprofen (Reumophan Vit) (Ketoprofen (Reumophan Vit)) 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 (Reumophan Vit) (Ketoprofen (Reumophan Vit)) 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 (Reumophan Vit) (Ketoprofen (Reumophan Vit)) 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 (Reumophan Vit)® (Ketoprofen (Reumophan Vit)) 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 (Reumophan Vit) 100 in bottles of 100 capsules.

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

200 mg, NDC 0008-0690, opaque pink and off-white capsule marked with two radial bands and Ketoprofen (Reumophan Vit) 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 (Reumophan Vit) 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 (Reumophan Vit) (Ketoprofen (Reumophan Vit)) Capsules manufactured and distributed by Wyeth Pharmaceuticals

Ketoprofen (Reumophan Vit) Capsules distributed by Wyeth Pharmaceuticals

Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101

Rev 07/05

FDA rev date: 01/18/06

Usual Adult Dose for Drug Induced Vitamin/Mineral Deficiency

Drug Induced Neuritis:

Cycloserine: 100 to 300 mg/day orally in divided doses.

Isoniazid or penicillamine: 100 to 200 mg/day orally for 3 weeks or 25 to 100 mg/day for prophylaxis.

Oral contraceptives: 25 to 30 mg/day orally.

Acute Intoxication:

Hydralazine: 25 mg/kg. One-third of the dose should be administered IM and the remainder administered as an IV infusion over 3 hours.

Isoniazid: 1 to 4 grams IV as a first dose, then 1 g IM every 30 minutes until the total required dose has been administered (given with other anticonvulsants as needed). The total dose administered should equal the amount of isoniazid ingested.

Mushroom ingestion (genus Gyromitra): 25 mg/kg IV infused over 15 to 30 minutes. Repeat as needed to a maximum total daily dose of 15 to 20 g.

Usual Adult Dose for Dietary Supplement

Pyridoxine (Reumophan Vit) Deficiency:

10 to 25 mg/day orally, IM, or IV for 3 weeks followed by 2 to 5 mg/day from a multivitamin product.

Usual Adult Dose for Anemia

Sideroblastic, hereditary: 200 to 600 mg orally daily. If adequate response obtained, dose may be decreased to 30 to 50 mg orally daily.

If therapeutic response is not obtained after 1 to 2 months of Pyridoxine (Reumophan Vit) therapy, a different therapy should be considered.

Usual Adult Dose for Nausea/Vomiting

Nausea and vomiting of Pregnancy:

25 mg orally every 8 hours.

Usual Pediatric Dose for Drug Induced Vitamin/Mineral Deficiency

Drug Induced Neuritis (cycloserine, isoniazid, hydralazine, penicillamine) :

Treatment: 10 to 50 mg/day.

Prophylaxis: 1 to 2 mg/kg/day

Acute Intoxication:

Hydralazine: 25 mg/kg: One-third of the dose should be administered IM and the remainder administered as an IV infusion over 3 hours.

Isoniazid: Acute ingestion of known amount: Initial: A total dose of Pyridoxine (Reumophan Vit) equal to the amount of isoniazid ingested (maximum dose: 70 mg/kg, up to 5 g); administer at a rate of 0.5 to 1 g/minute until seizures stop or the maximum initial dose has been administered; may repeat every 5 to 10 minutes as needed to control persistent seizure activity and/or CNS toxicity. If seizures stop prior to the administration of the calculated initial dose, infuse the remaining Pyridoxine (Reumophan Vit) over 4 to 6 hours. Acute ingestion of unknown amount: Initial: 70 mg/kg (maximum dose: 5 g); administer at a rate of 0.5 to 1 g/minute; may repeat every 5 to 10 minutes as needed to control persistent seizure activity and/or CNS toxicity.

Mushroom ingestion (genus Gyromitra): 25 mg/kg IV. Repeat as needed up to a maximum total dose of 15 to 20 g.

Usual Pediatric Dose for Dietary Supplement

Pyridoxine (Reumophan Vit) Deficiency:

5 to 25 mg/day orally, IM, or IV for 3 weeks followed by 1.5 to 2.5 mg/day from a multivitamin product.

Usual Pediatric Dose for Seizures

Pyridoxine (Reumophan Vit)-dependent seizures:

10 to 100 mg PO, IM, or IV initially, followed by 2 to 100 mg orally daily.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Drug dependence has been reported in patients withdrawn from the drug at doses of 200 mg per day.

Pyridoxine (Reumophan Vit) should not be administered intravenously to patients with heart disease.

Sensory neuropathy with axonal degeneration has been reported following a single large dose of Pyridoxine (Reumophan Vit) (10 g) administered intravenously. It may rarely occur following chronic administration of lower doses.

Dialysis

Data not available

Other Comments

Administer parenteral Pyridoxine (Reumophan Vit) by slow IV push.

When administering large parenteral doses, the patients heart rate, respiratory rate and blood pressure should be monitored closely.

Oral Pyridoxine (Reumophan Vit) may be given with or without food.

Urinary excretion of 4-pyridoxic acid <0.1 mg/24 hours is suggestive of a deficiency.

Pyridoxine (Reumophan Vit) (Pyridoxine (Reumophan Vit)) is found in meat, liver, whole-grain breads and cereals, soybeans, vegetables, eggs, peanuts, walnuts, and corn.

Average Adequate Intake (AI) in Adults:

>=19 to 50 years: 1.3 mg/day

>=51 years:

Men: 1.7 mg/day

Women: 1.5 mg/day

Recommended Daily Allowance (RDA) in Pediatrics:

1 to 3 years: 0.5 mg/day

4 to 8 years: 0.6 mg/day

Average Adequate Intake (AI) in Pediatrics:

0 to 6 months: 0.1 mg/day

7 to 12 months: 0.3 mg/day

9 to 13 years: 1 mg/day

Males:

>=14 years: 1.3 mg/day

Female:

>=14 years: 1.2 mg/day

Usual Adult Dose for Beriberi

10 to 20 mg IM three times daily for up to 2 weeks. Thereafter, use an oral therapeutic multivitamin preparation containing 5 to 10 mg Thiamine (Reumophan Vit) daily for one month. A complete and balanced diet should follow.

Neuritis of pregnancy:

If vomiting severe to preclude oral therapy, give 5 to 10 mg IM daily.

'Wet' with myocardial failure:

Treat as an emergency cardiac condition. Thiamine (Reumophan Vit) is administered slowly by the IV route.

Usual Adult Dose for Thiamine (Reumophan Vit) Deficiency

If dextrose administered: to patients with marginal Thiamine (Reumophan Vit) status, give 100 mg in each of the first few liters of IV fluid to avoid precipitating heart failure.

Usual Adult Dose for Vitamin/Mineral Supplementation

50 to 100 mg orally once a day

Usual Adult Dose for Wernicke's Encephalopathy

100 mg IV as an initial dose followed by 50 to 100 mg/day IM or IV until the patient is on a regular, balanced, diet.

Usual Pediatric Dose for Beriberi

10 to 25 mg IM or IV daily (if critically ill), or 10 to 50 mg orally every day for 2 weeks, then 5 to 10 mg orally daily for 1 month. If collapse occurs: 25 mg IV. Administer with caution.

Usual Pediatric Dose for Thiamine (Reumophan Vit) Deficiency

If dextrose administered: to patients with marginal Thiamine (Reumophan Vit) status, give 100 mg in each of the first few liters of IV fluid to avoid precipitating heart failure.

Usual Pediatric Dose for Vitamin/Mineral Supplementation

Infants: 0.3 to 0.5 mg orally once a day; children: 0.5 to 1 mg orally once a day.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

If hypersensitivity to Thiamine (Reumophan Vit) is suspected, administer a skin test: one-hundredth of the dose intradermally and observe patient for at least 30 minutes. If no reaction occurs, full dose can be administered.

Precautions

Serious hypersensitivity/anaphylactic reactions have been reported, especially after repeated administration. A skin test should be performed on patients who are suspected of drug allergies or previous reactions to Thiamine (Reumophan Vit), and any positive responders should not receive Thiamine (Reumophan Vit) by injection.

Deaths have been reported after the use of IV or IM administration of Thiamine (Reumophan Vit).

Thiamine (Reumophan Vit) injection contains aluminum. Toxic levels of aluminum may occur if prolonged parenteral administration is used in patients with kidney impairment.

Dialysis

Data not available

Other Comments

Oral Thiamine (Reumophan Vit) may be given with or without food.

Parenteral Thiamine (Reumophan Vit) should be administered IM or by slow IV injection.

Dietary sources of Thiamine (Reumophan Vit) include pork, beef, whole grains, yeast, fresh vegetables and legumes.

Recommended Dietary Allowances (RDA) in Adults:

Males: 1.2 mg daily

Female: 1.1 mg daily

Recommended Daily Allowance (RDA) in Pediatrics:

1 to 3 years: 0.5 mg/day

4 to 8 years: 0.6 mg/day

9 to 13 years: 0.9 mg/day

Males -14 to 18 years: 1.2 mg/day

Females - 14 to 18 years: 1.0 mg/day

Average Adequate Intake (AI) for healthy breast-fed infants:

0 to 6 months: 0.2 mg/day

7 to 12 months: 0.3 mg/day

See also:
What is the most important information I should know about Chlorzoxazone (Reumophan Vit)?

Chlorzoxazone (Reumophan Vit) Chlorzoxazone (Reumophan Vit) is contraindicated in patients with known intolerance to the drug.

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

Ketoprofen (Reumophan Vit) (Ketoprofen (Reumophan Vit)) and Ketoprofen (Reumophan Vit) are contraindicated in patients who have shown hypersensitivity to Ketoprofen (Reumophan Vit).

Ketoprofen (Reumophan Vit) (Ketoprofen (Reumophan Vit)) and Ketoprofen (Reumophan Vit) 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 (Reumophan Vit) have been reported in such patients.

Ketoprofen (Reumophan Vit) (Ketoprofen (Reumophan Vit)) and Ketoprofen (Reumophan Vit) 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 Pyridoxine (Reumophan Vit)?

Contraindications for Pyridoxine (Reumophan Vit) (Pyridoxine (Reumophan Vit)-HCl Microencapsulated)

Pyridoxine (Reumophan Vit) is contraindicated in those hypersensitive to any component of a Pyridoxine (Reumophan Vit)-containing product.

See also:
What is the most important information I should know about Thiamine (Reumophan Vit)?

A history of sensitivity to Thiamine (Reumophan Vit) or to any of the ingredients in this drug is a contraindication.

Use Chlorzoxazone (Reumophan Vit) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Chlorzoxazone (Reumophan Vit) by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you miss a dose of Chlorzoxazone (Reumophan Vit), 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 Chlorzoxazone (Reumophan Vit).

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

• Ketoprofen (Reumophan Vit) 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 (Reumophan Vit) extended-release capsules refilled.
• Take Ketoprofen (Reumophan Vit) 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 (Reumophan Vit) extended-release capsules whole. Do not break, crush, or chew before swallowing.
• Take Ketoprofen (Reumophan Vit) 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 (Reumophan Vit) 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 (Reumophan Vit) extended-release capsules.

Use Pyridoxine (Reumophan Vit) (Pyridoxine (Reumophan Vit) extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pyridoxine (Reumophan Vit) (Pyridoxine (Reumophan Vit) extended-release tablets may be taken with or without food.
• Swallow Pyridoxine (Reumophan Vit) (Pyridoxine (Reumophan Vit) extended-release tablets whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of Pyridoxine (Reumophan Vit) (Pyridoxine (Reumophan Vit) extended-release tablets and you are taking it regularly, take it as soon as possible. If several hours have passed or 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 Pyridoxine (Reumophan Vit) (Pyridoxine (Reumophan Vit) extended-release tablets.

Use Thiamine (Reumophan Vit) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Thiamine (Reumophan Vit) is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Thiamine (Reumophan Vit) at home, a health care provider will teach you how to use it. Be sure you understand how to use Thiamine (Reumophan Vit). Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Thiamine (Reumophan Vit) if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Thiamine (Reumophan Vit), contact your doctor to find out what to do.

Ask your health care provider any questions you may have about how to use Thiamine (Reumophan Vit).

Chlorzoxazone (Reumophan Vit) is used to treat muscle spasms/pain. It is usually used along with rest, physical therapy, and other treatment. It works by helping to relax the muscles.

How to use Chlorzoxazone (Reumophan Vit)

Take this medication by mouth with or without food as directed by your doctor, usually 3 or 4 times a day.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or take it more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Tell your doctor if your condition does not improve 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 (Reumophan Vit) in the treatment of ankylosing spondylitis.

Use: Labeled Indications

Pyridoxine (Reumophan Vit) deficiency: Treatment and prevention of Pyridoxine (Reumophan Vit) (vitamin B) deficiency.

Off Label Uses

Ethylene glycol poisoning

The American Academy of Clinical Toxicology guidelines recognize the lack of human clinical data for this use and consider Pyridoxine (Reumophan Vit) as an adjunctive cofactor therapy in ethylene glycol poisoning without a formal or evidence-based recommendation, especially in patients who may have vitamin deficiencies (eg, patients with alcoholism). Additional data may be necessary to further define the role of Pyridoxine (Reumophan Vit) in this condition.

Peripheral neuropathy associated with isoniazid therapy for Mycobacterium tuberculosis (prevention)

Based on the Department of Health and Human Services (DHHS) Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, Pyridoxine (Reumophan Vit) is effective and recommended in the prevention of peripheral neuropathy associated with isoniazid therapy for Mycobacterium tuberculosis.

Use: Labeled Indications

Treatment of Thiamine (Reumophan Vit) deficiency (including Thiamine (Reumophan Vit) deficiency in pregnancy associated with neuropathy), beriberi (dry or wet variety), Wernicke encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to Thiamine (Reumophan Vit) deficiency, or when giving IV dextrose to individuals with marginal Thiamine (Reumophan Vit) status to avoid precipitation of heart failure; dietary supplement.

Off Label Uses

Alcohol withdrawal syndrome (adjunct)

Data from a limited number of patients studied suggest that Thiamine (Reumophan Vit) may be beneficial as an adjunct in the management of alcohol withdrawal syndrome to prevent Wernicke encephalopathy.

See also:
What other drugs will affect Chlorzoxazone (Reumophan Vit)?

Alcohol (Ethyl): May enhance the CNS depressant effect of Chlorzoxazone (Reumophan Vit). Alcohol (Ethyl) may decrease the serum concentration of Chlorzoxazone (Reumophan Vit). Specifically, chronic alcohol ingestion may decrease serum concentrations of Chlorzoxazone (Reumophan Vit). Monitor therapy

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

ARIPiprazole: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Monitor therapy

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification

Botulinum Toxin-Containing Products: Muscle Relaxants (Centrally Acting) may enhance the adverse/toxic effect of Botulinum Toxin-Containing Products. Specifically, the risk for increased muscle weakness may be enhanced. Monitor therapy

Brexanolone: CNS Depressants may enhance the CNS depressant effect of Brexanolone. Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Bromopride: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Consider therapy modification

Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect of Chlorzoxazone (Reumophan Vit). Chlormethiazole may increase the serum concentration of Chlorzoxazone (Reumophan Vit). Management: Consider reduced doses of Chlorzoxazone (Reumophan Vit) when combined with chlormethiazole. Monitor patients for increased Chlorzoxazone (Reumophan Vit) effects/toxicities (ie, CNS depression, sedation) if these agents are combined. Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

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

CYP2E1 Inhibitors (Strong): May increase the serum concentration of Chlorzoxazone (Reumophan Vit). Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Dofetilide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Dofetilide. Monitor therapy

Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Monitor therapy

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Consider therapy modification

Esketamine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Flibanserin: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Flibanserin. Monitor therapy

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Consider therapy modification

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Isoniazid: May increase the serum concentration of Chlorzoxazone (Reumophan Vit). Isoniazid may decrease the serum concentration of Chlorzoxazone (Reumophan Vit). Specifically, it may decrease Chlorzoxazone (Reumophan Vit) concentrations below baseline after isoniazid discontinuation. Monitor therapy

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Lemborexant: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lemborexant. Management: The maximum recommended dosage of lemborexant is 5 mg, no more than once per night, when coadministered with weak CYP3A4 inhibitors. Consider therapy modification

Lemborexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Consider therapy modification

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Monitor therapy

Lomitapide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lomitapide. Management: Patients on lomitapide 5 mg/day may continue that dose. Patients taking lomitapide 10 mg/day or more should decrease the lomitapide dose by half. The lomitapide dose may then be titrated up to a max adult dose of 30 mg/day. Consider therapy modification

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy

Minocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

NiMODipine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of NiMODipine. Monitor therapy

Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification

Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Avoid combination

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Monitor therapy

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Monitor therapy

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy

Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy

Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Consider therapy modification

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Tetrahydrocannabinol and Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination

Tolperisone: May enhance the adverse/toxic effect of Muscle Relaxants (Centrally Acting). Management: Monitor for increased sedation or CNS effects if tolperisone is combined with other centrally acting muscle relaxants. Consider decreasing the tolperisone dose if these agents are combined. Consider therapy modification

Triazolam: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Triazolam. Management: Consider triazolam dose reduction in patients receiving concomitant weak CYP3A4 inhibitors. Consider therapy modification

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Ubrogepant: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Ubrogepant. Management: In patients taking weak CYP3A4 inhibitors, the initial and second dose (if needed) of ubrogepant should be limited to 50 mg. Consider therapy modification

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification

See also:
What other drugs will affect Ketoprofen (Reumophan Vit)?

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

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

2. Aspirin: Ketoprofen (Reumophan Vit) does not alter aspirin absorption; however, in a study of 12 normal subjects, concurrent administration of aspirin decreased Ketoprofen (Reumophan Vit) protein binding and increased Ketoprofen (Reumophan Vit) 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 (Reumophan Vit) is not recommended.

3. Diuretic: Hydrochlorothiazide, given concomitantly with Ketoprofen (Reumophan Vit), 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 (Reumophan Vit) and digoxin were concomitantly administered, Ketoprofen (Reumophan Vit) did not alter the serum levels of digoxin.

5. Warfarin: In a short-term controlled study in 14 normal volunteers, Ketoprofen (Reumophan Vit) 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 (Reumophan Vit) treatment. Because prostaglandina play an important role in hemostasis and Ketoprofen (Reumophan Vit) has an effect on platelet function as well, concurent therapy with Ketoprofen (Reumophan Vit) and warfarin requires close monitoring of patients on both drugs.

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

7. Methotrexate: Ketoprofen (Reumophan Vit), 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 (Reumophan Vit) is coadministered with lithium.

DRUG/LABORATORY TEST INTERACTIONS: EFFECT ON BLOOD COAGULATION

Ketoprofen (Reumophan Vit) 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 Pyridoxine (Reumophan Vit)?

Altretamine: Pyridoxine (Reumophan Vit) may diminish the therapeutic effect of Altretamine. Specifically when altretamine is used in combination with Cisplatin the response duration may be diminished. Management: Consider avoiding concomitant use of Pyridoxine (Reumophan Vit) in a altretamine/cisplatin regimen. Although Pyridoxine (Reumophan Vit) may have beneficial effects on altretamine-associated neurotoxicity, it may reduce the duration of response to altretamine. Consider therapy modification

Barbiturates: Pyridoxine (Reumophan Vit) may increase the metabolism of Barbiturates. Apparent in high Pyridoxine (Reumophan Vit) doses (eg, 200 mg/day) Monitor therapy

Fosphenytoin: Pyridoxine (Reumophan Vit) may increase the metabolism of Fosphenytoin. This is most apparent in high Pyridoxine (Reumophan Vit) doses (e.g., 80 mg to 200 mg daily) Monitor therapy

Levodopa-Containing Products: Pyridoxine (Reumophan Vit) may diminish the therapeutic effect of Levodopa-Containing Products. Management: The concomitant use of Pyridoxine (Reumophan Vit) and levodopa (in the absence of a dopa decarboxylase inhibitor (DDI)) should be avoided. Use of a DDI (eg, carbidopa) with levodopa will essentially eliminate the risk of this interaction. Consider therapy modification

Phenytoin: Pyridoxine (Reumophan Vit) may increase the metabolism of Phenytoin. This is most apparent in high Pyridoxine (Reumophan Vit) doses (e.g., 80 mg to 200 mg daily) Monitor therapy

See also:
What other drugs will affect Thiamine (Reumophan Vit)?

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

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

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

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

With the simultaneous use with urological means reduced their effectiveness.

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

When Thiamine (Reumophan Vit) applied simultaneously with diazepam may decrease excretion of diazepam.

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

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

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

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

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

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

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

At simultaneous application of Thiamine (Reumophan Vit) with ethinylestradiol increases absorption of paracetamol 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 Chlorzoxazone (Reumophan Vit)?

Applies to Chlorzoxazone (Reumophan Vit): oral capsule, oral tablet

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

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Chlorzoxazone (Reumophan Vit):

Rare

• Bloody or black, tarry stools
• clay-colored stools
• constipation
• cough
• dark urine
• decreased appetite
• difficulty swallowing
• dizziness
• fast heartbeat
• fever
• headache
• hives
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• nausea and vomiting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• severe stomach pain
• shortness of breath
• skin rash
• swelling of the feet or lower legs
• tightness in the chest
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• wheezing
• yellow eyes or skin

If any of the following symptoms of overdose occur while taking Chlorzoxazone (Reumophan Vit), get emergency help immediately:

Symptoms of overdose:

• Diarrhea
• difficult or troubled breathing
• drowsiness
• general feeling of discomfort or illness
• headache
• irregular, fast or slow, or shallow breathing
• lightheadedness
• nausea
• pale or blue lips, fingernails, or skin
• sluggishness
• vomiting

Minor Side Effects

Some of the side effects that can occur with Chlorzoxazone (Reumophan Vit) 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:

Rare

• Bruising
• large, flat, blue, or purplish patches in the skin
• small red or purple spots on the skin

See also:
What are the possible side effects of Ketoprofen (Reumophan Vit)?

The incidence of common adverse reactions (above 1%) was obtained from a population of 835 Ketoprofen (Reumophan Vit) (Ketoprofen (Reumophan Vit)) -treated patients in double-blind trials lasting from 4 to 54 weeks and in 622 Ketoprofen (Reumophan Vit)-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 (Reumophan Vit) (Ketoprofen (Reumophan Vit)) once a day or 75 mg of Ketoprofen (Reumophan Vit) (Ketoprofen (Reumophan Vit)) 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 (Reumophan Vit) 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 Pyridoxine (Reumophan Vit)?

Applies to Pyridoxine (Reumophan Vit): capsule, injectable, solution, tablet, tablet enteric coated, tablet extended release

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

Severity: Moderate

If any of the following side effects occur while taking Pyridoxine (Reumophan Vit), check with your doctor or nurse as soon as possible:

With large doses

• Clumsiness
• numbness of hands or feet

See also:
What are the possible side effects of Thiamine (Reumophan Vit)?

Applies to Thiamine (Reumophan Vit): capsule, solution, tablet, tablet enteric coated

As well as its needed effects, Thiamine (Reumophan Vit) (the active ingredient contained in Thiamine (Reumophan Vit)) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Thiamine (Reumophan Vit), check with your doctor immediately:

Rare - Soon after receiving injection only

• Coughing
• difficulty in swallowing
• hives
• itching of skin
• swelling of face, lips, or eyelids
• wheezing or difficulty in breathing