Promax - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Promax

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Promax is an analgesic, antipyretic, antiplatelet drug of the group of non-steroidal anti-inflammatory drugs (NSAIDs); reduces the severity or eliminates pain syndrome (including joint pain at rest and movement), reduces morning stiffness and swelling of the joints, increasing the range of motion.

Release form and composition

Dosage form of Promax - film-coated tablets: white, capsule-like, on one side there is an imprint "H1" (10 pcs. In PVC blisters and aluminum foil, in a cardboard box, 1 blister each).

Composition of 1 tablet:

• Active ingredient: naproxen sodium - 275 or 550 mg (which corresponds to 250 or 500 mg of naproxen);
• Auxiliary components: sodium lauryl sulfate, magnesium stearate, sodium croscarmellose, povidone, colloidal silicon dioxide, hydrogenated vegetable oil, simethicone emulsion, microcrystalline cellulose, methacrylic acid copolymer, hydroxypropyl methylcellulose, lactose, talcum dioxide purified.

Indications for use

• Pain syndrome of mild and moderate severity: dysmenorrhea, disorders of the musculoskeletal system (pain in the spine, joint and muscle pain), toothache and headache;
• Rheumatic diseases: osteoarthritis, rheumatoid arthritis, ankylosing spondylitis.

Contraindications

• Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase;
• Hematopoietic disorders;
• Severe hepatic (creatinine clearance (CC) less than 20 ml / min) and renal failure;
• Heart failure;
• Pregnancy (ІІІ trimester) and the period of breastfeeding;
• Children and adolescents up to 16 years old;
• Increased individual sensitivity to salicylates and other NSAIDs (including rhinitis, asthmatic syndrome, nasal polyps, urticaria);
• Hypersensitivity to naproxen and other components of Promax.

With caution, in the minimum effective dose, the drug is taken in renal and hepatic insufficiency of moderate and mild severity, in old age, as well as in the I and II trimesters of pregnancy.

Method of administration and dosage

The tablets are taken orally after a meal.

The following dosing regimen of Promax is recommended:

• Pain reliever: initial dose - 500 mg, then 250 mg every 6-8 hours as needed; the maximum daily dose is 1500 mg;
• Antirheumatic: a daily dose of 500-1000 mg, divided into 2 doses, in the case of a pronounced exacerbation of rheumatic disease, it can be increased to 1500 mg (for a limited period of time); the maximum daily dose is 1750 mg.

Arthritis treatment lasts 2 weeks, but naproxen may need to be taken continuously for 2 to 4 weeks until maximum results are achieved.

Without medical advice and observation of the patient, the duration of the course of therapy with Promax should not exceed 3 days.

Side effects

If the recommended dosing regimen is observed, naproxen is well tolerated.

Most often, due to taking high doses of the drug and / or a long period of therapy, the following side reactions may occur:

• Gastrointestinal tract (GIT): nausea, heartburn, vomiting, diarrhea, constipation, dyspepsia, flatulence, abdominal pain, gastric perforation and / or gastric bleeding, melena, hematemesis, stomatitis (including ulcerative), exacerbation of ulcerative colitis and Crohn's disease, stomach ulcer, gastritis, esophagitis, pancreatitis;
• Blood system and lymphatic system: thrombocytopenia, neutropenia, granulocytopenia, leukopenia, eosinophilia, aplastic and hemolytic anemia;
• Immune system: hypersensitivity reactions (angioedema, bronchospasm);
• Metabolism, metabolism: hyperkalemia;
• Mental disorders: sleep disturbances, insomnia, depression, confusion, hallucinations;
• Central and peripheral nervous system: paresthesias, seizures, vertigo, drowsiness, headache, retrobulbar optic neuritis, impaired concentration, cognitive impairment, aseptic meningitis (especially in patients with a history of autoimmune diseases such as Sharp's syndrome (mixed connective tissue diseases) and systemic lupus erythematosus), accompanied by stiff neck muscles, headache, fever, disorientation;
• Organ of vision: corneal opacity, visual impairment, papilloedema (edema of the optic nerve head), papillitis;
• Hearing organ: tinnitus, hearing impairment;
• Cardiovascular system: palpitations, edema, heart failure, arterial hypertension (AH), vasculitis, a slight increase in the risk of arterial thrombosis (myocardial infarction or stroke);
• Respiratory system: shortness of breath, eosinophilic pneumonia, asthma, pulmonary edema;
• Hepatobiliary system: increased levels of liver enzymes, jaundice;
• Skin and subcutaneous tissue: alopecia, skin rash, pruritus, urticaria, purpura, bruising, hyperhidrosis, polymorphic erythema, malignant exudative erythema, epidermal necrolysis, systemic lupus erythematosus and photosensitivity reactions similar to symptoms with chronic hematoporphyria and epidermis;
• Musculoskeletal system and connective tissue: muscle weakness and muscle pain;
• Urinary system: interstitial nephritis, glomerulonephritis, nephrotic syndrome, necrotizing papillitis, renal failure, hematuria;
• Reproductive system: female infertility;
• General disorders: fever, thirst, fatigue, malaise.

In case of severe adverse reactions, therapy should be discontinued immediately.

Overdose symptoms are: heartburn, abdominal pain, nausea, vomiting, gastrointestinal bleeding, headache; rarely - disorientation, irritability, dizziness, drowsiness, tinnitus, diarrhea; in more difficult cases - melena, bloody vomiting, disturbance of consciousness, respiratory disorders, convulsions, renal failure.

For the treatment of the condition, gastric lavage, intake of activated charcoal, misoprostol, antacids, proton pump inhibitors, H ₂ receptor inhibitors, and other types of symptomatic treatment are recommended.

special instructions

In the case of an infectious disease, the antipyretic and anti-inflammatory effects of naproxen should be taken into account, since they can mask the symptoms of the inflammatory process.

If the concentration of 17-ketosteroids is to be analyzed, it is required to stop taking naproxen at least 48 hours before the study.

Reception of Promax should be discontinued at least 48 hours before the start of the planned major surgery and in the presence of significant fresh wounds.

Patients with porphyria and / or epilepsy taking naproxen should be monitored closely by a doctor.

1 tablet of Promax 500 mg contains 50 mg of sodium, Promax 250 mg - 25 mg of sodium, which must be taken into account when the patient follows a salt-free diet.

When working with complex mechanisms and driving vehicles, care must be taken, since possible adverse reactions from taking Promax, such as drowsiness, dizziness, impaired concentration, etc. cannot be excluded.

Drug interactions

• Furosemide - a decrease in its diuretic effect is possible;
• Acetylsalicylic acid, other NSAIDs and analgesics (including selective COX-2 blockers) - the risk of side effects increases;
• Indirect anticoagulants - their effect is enhanced;
• Antacids containing aluminum and magnesium - reduce the absorption of naproxen;
• Probenecid - increased plasma concentration of naproxen and increases its T ¹ / ₂;
• Derivatives of hydantoin or sulfonylureas (drugs that bind to blood plasma proteins) - compete with naproxen for binding to proteins (use with caution);
• Methotrexate - decreases its tubular excretion, which can increase the toxicity of methotrexate;
• Cyclosporine, angiotensin-converting enzyme (ACE) inhibitors - may increase the risk of renal dysfunction;
• Zidovudine (according to in vitro studies) - its concentration in blood plasma increases;
• Tacrolimus - development of nephrotoxicity is possible;
• Mifepristone - naproxen, like other NSAIDs, can reduce its effectiveness (an interval of 8-12 days should be observed after taking mifepristone).

Analogs

Analogs of Promax are: Naproxen Acri, Naproxen, Nalgezin Forte, Algezir Ultra.

Terms and conditions of storage

Store at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Available without a prescription.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!