Voltaren rectal suppositories 50mg N10
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Active ingredients
Diclofenac
Release form
Suppositories
Composition
1 suppository contains: diclofenac sodium 50 mg. Auxiliary substances: solid fat - up to 2 g.
Pharmacological effect
anti-inflammatory local, analgesic local
Pharmacokinetics
Absorption and distribution in the body. The amount of diclofenac that is absorbed systemically from a Voltaren patch within 24 hours is similar to that when using an equivalent amount of Voltaren Emulgel (1% external gel). 99.7% of diclofenac binds to serum proteins, mainly albumin (99.4%). Elimination. The total systemic clearance of diclofenac from plasma is (263 ± 56) ml / min. The final T1 / 2 in the blood plasma is 1-2 hours. Four metabolites, including two active, also have a short T1 / 2 - 1-3 hours. One metabolite - 3'-hydroxy-4'-methoxydiclofenac - has a longer half-life, however, is inactive. Diclofenac and its metabolites are excreted mainly in the urine. In patients with impaired renal function, the accumulation of diclofenac and its metabolites does not occur. In patients with chronic hepatitis or non-compensated cirrhosis, the kinetics and metabolism of diclofenac follow the same pattern as in patients without liver disease. Preclinical studies have shown the safety of the use of the drug.
Indications
back pain in inflammatory and degenerative diseases of the spine (radiculitis, osteoarthritis, lumbago, sciatica); joint pains (joints of the fingers of the hands, knees, etc.) in rheumatoid arthritis, osteoarthrosis, muscle pain (due to sprains, overstrains, contusions, injuries ); inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tendovaginitis, bursitis, periarticular tissue lesions).
Contraindications
hypersensitivity to diclofenac or other components of the drug, a tendency to the occurrence of attacks of bronchial asthma, skin rashes or acute rhinitis when using acetylsalicylic acid or other NSAIDs; pregnancy (III trimester); violation of the integrity of the skin at the site of the intended gluing of the patch; (up to 15 years) .With caution: hepatic porphyria (exacerbation); erosive and ulcerative lesions of the digestive tract; severe violations of the liver and kidneys; chronic heart failure; bronchial asthma; elderly age.
Use during pregnancy and lactation
The use of the drug in pregnant women has not been studied, so the Voltaren transdermal patch should not be used during pregnancy, especially in the third trimester due to the possibility of lowering the tone of the uterus and / or premature closure of the arterial duct of the fetus. Studies on animals did not reveal any direct or indirect negative effects on pregnancy, childbirth, fetal and postembryonic development. There is no data on the penetration of the drug into breast milk, therefore the Voltaren transdermal patch is not recommended be used during breastfeeding.
Dosage and administration
The dose of the drug is selected individually, with the aim of reducing the risk of side effects is recommended to use the minimum effective dose, if possible, with the shortest possible period of treatment, in accordance with the purpose of treatment and the patient's condition. Suppositories must be injected into the rectum. It is recommended to use the drug after bowel emptying. Adults Recommended initial dose - 100-150 mg / day. In relatively mild cases of the disease, as well as for long-term therapy, 75-100 mg / day is sufficient. Frequency of use - 2-3 times. To relieve night pain or morning stiffness, Voltaren is prescribed in suppositories at bedtime, in addition to using the drug in pill form throughout the day; at the same time, the total daily dose should not exceed 150 mg. In case of primary dysmenorrhea, the daily dose is selected individually; usually it is 50-150 mg. The initial dose should be 50-100 mg; if necessary, for several menstrual cycles, it can be increased to 150 mg / day. Treatment should begin when the first symptoms appear. Depending on the dynamics of the clinical symptoms, treatment can be continued for several days. In a migraine attack, the initial dose is 100 mg. The drug is prescribed at the first symptoms of an approaching attack. If necessary, on the same day, you can additionally apply Voltaren in suppositories in a dose of up to 100 mg. If it is necessary to continue the treatment in the following days, the daily dose of the drug should not exceed 150 mg (in several injections). Children and adolescents under the age of 18 years dose, depending on the severity of the disease, should be divided into 2-3 single doses). For the treatment of juvenile rheumatoid arthritis, the daily dose may be maximized to 3 mg / kg (in several injections).The maximum daily dose - 150 mg should not be exceeded. Older patients (> 65 years old) Correction of the initial dose in patients aged 65 years and older is not required. In weakened patients, patients with low body weight, it is recommended to adhere to the minimum dose. Patients with cardiovascular diseases or a high risk of cardiovascular disease. The drug should be used with particular caution in patients with cardiovascular diseases (including those with uncontrolled arterial). hypertension) or high risk of developing diseases of the cardiovascular system. If necessary, long-term therapy (more than 4 weeks) in these patients should use the drug in a daily dose not exceeding 100 mg. Patients with impaired mild to moderate renal function. There is no data on the need for dose adjustment when using the drug in patients with mild renal impairment and moderate severity due to the lack of studies of the safety of the drug in this category of patients. Patients with impaired liver function mild to moderate severity and dose adjustment in the use of the drug in patients with impaired liver function of mild and moderate severity due to the lack of studies of the safety of the drug in this category of patients.
Side effects
Undesirable reactions are mainly characterized by moderately pronounced and passing skin manifestations at the site of the patch application. Very rare manifestations (<1/10000) Local reactions: pustular rash. Systemic reactions: generalized skin rash; allergic reactions (urticaria, hypersensitivity - angioedema, asthma attacks, bronchospastic reactions), photosensitization reactions. Rare (≥1 / 10000, <1/1000) Local reactions: bullous dermatitis. ) Local reactions: erythema, dermatitis, incl. contact dermatitis (symptoms - erythema, itching, swelling of the treated skin area, rash, papules, vesicles, desquamation), eczema.
Overdose
Extremely low systemic absorption of active ingredients and the dosage form of the drug for external use makes overdose almost impossible.
Interaction with other drugs
Voltaren plaster may enhance the effect of drugs that cause photosensitization. Clinically significant interaction with other drugs is not described.
special instructions
The Voltaren transdermal patch should be applied only to intact skin, avoiding contact with open wounds. The drug should not be allowed to enter the eyes and mucous membranes. When using Voltaren transdermal patch for too long a time, the possibility of systemic adverse reactions cannot be excluded. With the additional use of other dosage forms of diclofenac, its quantitative content in the patch should be considered in order not to exceed the maximum daily dose of diclofenac (150 mg / day). The effect on the ability to drive motor vehicles and control mechanisms. Does not affect.