Zotec-300 (dexibuprofen) coated tablets 300 mg. №10

Description

Zotec-300 (dexibuprofen) coated tablets 300 mg. №10

Composition

active substance: dexibuprofen;

1 film-coated tablet contains dexibuprofen 200 mg or 300 mg or 400 mg;

Excipients: microcrystalline cellulose, colloidal anhydrous silica, talc, calcium carmellose, shell composition: hypromellose, titanium dioxide (E 171), talc, dichloromethane, isopropyl alcohol.

Dosage form

Film-coated tablets.

Basic physical and chemical properties:

• Zotec-200: round biconvex tablets, film-coated white.
• Zotec-300 and Zotec-400: oblong biconvex tablets, film-coated white with a score line on one side.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory and anti-rheumatic drugs. Derivatives of propionic acid. Dexibuprofen. ATX code M01A E14.

Pharmacological properties

Dexibuprofen (Zotec-300) is a pharmacologically active isomer of racemic ibuprofen, which belongs to non-selective nonsteroidal anti-inflammatory drugs (NSAIDs). Its mechanism of action is associated with inhibition of prostaglandin synthesis. The drug has antipyretic, analgesic and anti-inflammatory properties.

The results of comparative clinical trials in the treatment of osteoarthritis, dysmenorrhea, pain (including toothache) indicate that dexibuprofen at a dose 2 times lower than ibuprofen has similar effectiveness.

Indication

Symptomatic treatment of mild to moderate pain of various origins: toothache, back pain, joint pain, muscle pain, rheumatic pain, dysmenorrhea.

Contraindication

Hypersensitivity to dexibuprofen, other NSAIDs or to other components of the drug; use in patients in whom substances with a similar mechanism of action, such as acetylsalicylic acid and other NSAIDs, cause asthma attacks, bronchospasm, acute rhinitis or lead to the development of nasal polyps, urticaria or angioneurotic edema; history of bleeding or perforation of the gastrointestinal tract associated with NSAID use; active phase of peptic ulcer disease / bleeding in the digestive tract, history of peptic ulcer disease / bleeding in the digestive tract (at least two confirmed facts of ulcer or bleeding); Crohn’s disease or nonspecific ulcerative colitis in the active phase; cerebrovascular bleeding or other bleeding in the active phase; hematopoietic disorders or blood clotting; severe hepatic failure, severe renal failure, severe heart failure.

Method of application and dosage

The dosage regimen is set by the doctor individually taking into account the intensity of the pain syndrome. Adults should be prescribed 1-2 tablets (200-400 mg of dexibuprofen) 3 times daily after meals. The recommended starting dose is 200 mg of dexibuprofen. The recommended daily dose is 600-900 mg of dexibuprofen, divided into 3 doses. Higher daily dose – 1200 mg, higher single dose – 400 mg.

With dysmenorrhea, the highest single dose is 300 mg, the highest daily dose is 900 mg. It is desirable to take with food.

The drug is intended for symptomatic relief of pain, but if the symptoms persist for more than 3 days, accompanied by fever, headache or other phenomena, it is necessary to clarify the diagnosis and further adjust the treatment regimen.

The lowest effective dose should be used for the shortest time needed to relieve symptoms.

Children

The drug Zotec-300 should not be used in pediatric practice.

Overdose

Dexibuprofen is characterized by low acute toxicity. In most cases, the overdose is asymptomatic. The risk of developing symptoms occurs with the use of more than 80-100 mg / kg of ibuprofen (equivalent to 40-50 mg / kg of dexibuprofen).

• Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, headache, nystagmus, tinnitus, ataxia, in rare cases – gastrointestinal bleeding, hypotension, hypothermia, metabolic acidosis, convulsions, renal dysfunction, coma, adult respiratory distress syndrome, transient apnea attacks.
• Treatment: symptomatic therapy, no specific antidote. In case of overdose, take activated charcoal and perform gastric lavage (only within the first hour after poisoning). Forced diuresis, hemodialysis, and hemoperfusion are ineffective due to the high degree of binding of dexibuprofen to blood proteins.

Side effects:

• infections and invasions: exacerbation of inflammatory infectious processes (necrotizing fasciitis);
• from the immune system: angioneurotic edema, anaphylactic reactions, rhinitis, generalized hypersensitivity reactions, including bronchospasm, asthma, tachycardia, hypotension, shock, fever with rash, abdominal pain, headache, nausea, vomiting;
• from the blood and lymphatic system: prolongation of blood clotting time, thrombocytopenia, leukopenia, granulocytopenia, pancytopenia, agranulocytosis, aplastic anemia, hemolytic anemia;
• from the psyche: anxiety, psychotic reactions, depression, irritability, hallucinations;
• from the nervous system: drowsiness, headache, vertigo, dizziness, insomnia, restlessness, disorientation, confusion, agitation, aseptic meningitis;
• on the part of the visual organs: visual disturbances (including double vision), reversible toxic amblyopia;
• from the hearing organs: tinnitus, hearing impairment;
• from the digestive tract: dyspepsia, abdominal pain, diarrhea, nausea, vomiting, gastrointestinal ulcers and bleeding, gastritis, ulcerative stomatitis, melena, gastrointestinal perforation, flatulence, constipation, esophagitis, esophageal stricture, esophageal stricture, exacerbation colitis, ulcerative colitis, Crohn’s disease;
• from the urinary system: interstitial nephritis, nephrotic syndrome, renal failure can not be ruled out, taking into account the experience of NSAIDs;
• from the hepatobiliary system: liver dysfunction, hepatitis, jaundice;
• skin and subcutaneous tissue disorders: rash, urticaria, pruritus, purpura (including allergic purpura), erythema multiforme, epidermal necrolysis, systemic lupus erythematosus and other collagenosis, alopecia, photosensitivity reactions, Stevenslach-Johnsons syndrome ;
• general disorders: increased fatigue, increased sweating.