Naclofen (diclofenac sodium) suppositories 50 mg. №10

Description

Naclofen composition
active substance: 1 suppository contains diclofenac sodium – 50 mg;
excipient: solid fat.

Dosage form
Suppositories.

Pharmacological properties
Naclofen is a non-steroidal anti-inflammatory drug with analgesic, anti-inflammatory and antipyretic properties. It inhibits the activity of cyclooxygenase and thus – the synthesis of prostaglandins. During treatment with diclofenac, decreases in prostaglandin levels were observed in urine, gastric mucosa and synovial fluid.
The drug should be used in the treatment of all forms of rheumatic diseases and to suppress pain of various origins.

Indication:

• inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, including spondyloarthritis;
• pain syndromes from the spine;
• rheumatic diseases of extraarticular soft tissues;
• post-traumatic and postoperative pain syndromes accompanied by inflammation and edema, in particular after dental and orthopedic operations;
• gynecological diseases that are accompanied by pain and inflammation, such as primary dysmenorrhea and adnexitis;
• migraine attacks;
• acute attacks of gout;
• as an adjunct in severe inflammatory diseases of the ENT organs, which are accompanied by pain, such as pharyngotonsillitis, otitis.

According to general therapeutic principles, the underlying disease should be treated with basic therapy. Fever in itself is not an indication for use of the drug.

Contraindication:

• hypersensitivity to the active substance or to any of the excipients;
• history of bleeding or perforation of the gastrointestinal tract associated with previous NSAID treatment;
• active form of peptic ulcer / bleeding or recurrent peptic ulcer / bleeding in the anamnesis (two or more separate episodes of established ulcer or bleeding);
• the last trimester of pregnancy;
• inflammatory bowel disease (eg, Crohn’s disease or ulcerative colitis);
• liver failure;
• renal failure;
• congestive heart failure (NYHA II-IV);
• coronary heart disease in patients with angina, myocardial infarction;
• peripheral artery disease;
• cerebrovascular disease in patients who have suffered a stroke or have episodes of transient ischemic attacks;
• treatment of perioperative pain during coronary artery bypass grafting (or use of an artificial circulation device);
• Naclofen, like other nonsteroidal anti-inflammatory drugs (NSAIDs), is contraindicated in patients who develop asthma attacks, urticaria, angioneurotic edema, or acute rhinitis in response to acetylsalicylic acid or other NSAIDs;
• proctitis.

Children
Naclofen suppositories of 50 mg should not be prescribed to children under 14 years of age due to the high content of the active substance.

Use during pregnancy or breastfeeding
Naclofen should not be used by women during breast-feeding to avoid adverse effects on the infant.

Method of application and dosage.
To minimize side effects, the minimum effective dose should be used for the shortest period of time, taking into account the treatment objectives of each individual patient.
Naclofen suppositories should be used in appropriate doses in adult patients who do not tolerate oral tablets.
Do not take orally, only for rectal administration.
Treatment can be carried out using one dosage form or in combination based on a daily dose of 150 mg.
The initial dose is 100-150 mg of diclofenac per day depending on the severity of the disease, ie 1 suppository 2-3 times a day. The maintenance dose is 100 mg of diclofenac per day, ie 1 suppository twice a day.

• In primary dysmenorrhea, the daily dose should be selected individually, it is from 50 to 150 mg. The initial dose may be 50-100 mg / day, but if necessary it can be increased over several menstrual cycles to a maximum of 200 mg / day. The drug should be used after the first pain symptoms and continued for several days depending on the dynamics of regression of symptoms.
• For the treatment of migraine attacks, the course should be started at a dose of 100 mg at the first signs of an attack. If necessary, you can use a second suppository (100 mg of diclofenac) on the same day. If necessary, in the following days, treatment can be continued (daily dose should not exceed 150 mg, the dose should be divided into 2-3 applications).
• In the treatment of juvenile rheumatoid arthritis, the daily dose can be increased to 3 mg / kg, which is the maximum daily dose and should not exceed 150 mg per day.

The method of application of suppositories.
Naclofen suppositories should be injected into the rectum as deeply as possible, preferably after bowel cleansing. Suppositories should not be divided into parts, as such a change in the method of application of the drug may lead to a violation of the distribution of the active substance.

Overdose
Symptoms. There is no typical clinical picture of diclofenac overdose. Overdose may cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhea, dizziness, disorientation, agitation, coma, drowsiness, tinnitus or convulsions. Acute renal failure and liver damage are possible in case of severe intoxication.
Therapeutic measures. If necessary, treatment is symptomatic. Within 1 hour after administration of a potentially toxic amount of the drug, the use of activated charcoal should be considered. In addition, adults should consider gastric lavage within 1 hour after administration of a potentially toxic amount of the drug. In case of frequent or prolonged convulsions, diazepam should be administered intravenously. Depending on the patient’s clinical condition, other measures may be indicated.

Side effects
Taking this drug can cause side effects in the form of:

• pain in the epigastrium;
• nausea, vomiting, diarrhea, abdominal cramps;
• dyspepsia, gastrointestinal bleeding;
• ulcers of the stomach and intestines;
• glossitis, stomatitis, lesions of the esophageal mucosa;
• intestinal adhesions;
• constipation, pancreatitis;
• headaches, drowsiness, anxiety, nightmares, hair loss;
• skin rashes, urticaria, eczema, erythema multiforme;
• edema, renal failure, hematuria, nephrotic syndrome, papillary necrosis;
• hepatitis, agranulocytosis, thrombocytopenia, leukopenia, anemia;
• tachycardia, chest pain, lowering blood pressure.

Storage conditions and periods
Naclofen is stored for up to 3 years at temperatures up to 25 ° C.