Instructions for Indomethacin-Sopharma ointment 10% tube 40 g
Composition
active ingredient: indomethacin;
1 g of ointment contains 0.1 g of indomethacin;
excipients: lavender oil, lanolin, white soft paraffin, dimethyl sulfoxide, yellow wax, colloidal anhydrous silicon dioxide.
Dosage form
Ointment.
Main physicochemical properties: homogeneous yellow ointment with a specific odor.
Pharmacotherapeutic group
Anti-inflammatory drugs, non-steroidal for topical use. Indomethacin.
ATX code M02A A23.
Pharmacological properties
Pharmacodynamics
Indomethacin is a derivative of indoleacetic acid and belongs to the group of nonsteroidal anti-inflammatory drugs. Indomethacin exerts a strong inhibitory effect on prostaglandin synthesis by inhibiting the enzyme cyclooxygenase, which plays a significant role in inflammatory processes, pain and hyperthermia. It has an antipyretic effect and reversibly inhibits platelet aggregation. When applied topically, indomethacin has a direct anti-inflammatory and analgesic effect on inflamed tissues.
Pharmacokinetics
The ointment is well absorbed through the skin and accumulates in the subcutaneous tissues in therapeutic concentrations, including joints and synovial fluid. It is excreted by the kidneys in the form of metabolites and in a small amount in unchanged form, including topical application, and in a small amount is excreted through the biliary tract to the intestines.
Indication
– Additional remedy in the complex treatment of acute and chronic rheumatoid arthritis, osteoarthritis, osteoarthrosis, ankylosing spondylitis, psoriatic polyarthritis, gouty arthritis;
– localized forms of extra-articular rheumatism of the musculoskeletal system: tendinitis, synovitis, tendovaginitis, inflammation of fascia and articular ligaments, bursitis;
– local symptomatic treatment of inflammation, pain and swelling in post-traumatic lesions of the musculoskeletal system - sprains, dislocations, bruises.
Contraindication
Hypersensitivity to the active substance or to any of the excipients of the drug. Hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) with clinical manifestations of asthmatic attack, urticaria or allergic rhinitis.
Interaction with other medicinal products and other types of interactions
With topical use of indomethacin, due to minimal absorption, interactions with other drugs are unlikely.
Concomitant use of indomethacin with another NSAID, including a selective COX-2 inhibitor, should be avoided due to an increased risk of adverse reactions.
Concomitant use of indomethacin with aspirin or corticosteroids increases the risk of gastrointestinal complications.
Nonsteroidal anti-inflammatory drugs can interact with drugs that lower blood pressure, although this possibility is extremely small when used topically.
Application features
Sometimes taking nonsteroidal anti-inflammatory drugs can lead to damage to the gastrointestinal tract; deterioration of cardiac function in patients with cardiovascular failure; impaired liver and kidney function.
Despite the fact that after topical application to the skin, systemic absorption of indomethacin is minimal, patients with active gastric or duodenal ulcers, a history of kidney disease, and heart failure should be treated with the ointment only after consulting a doctor.
Treatment with the drug should be carried out with extreme caution and only after consulting a doctor in patients with manifestations of hypersensitivity to foods and medications or with allergic diseases - hay fever, bronchial asthma, nasal polyposis.
There is cross-hypersensitivity to other NSAIDs, so patients with hypersensitivity to any drugs in this group may also have hypersensitivity to indomethacin.
With prolonged treatment (more than 10 days), laboratory monitoring of leukocyte and platelet counts is recommended.
When used simultaneously with antibiotics, anticoagulants and antidiabetic drugs, it is necessary to monitor the relevant laboratory parameters.
It should be applied only to healthy, intact skin (in the absence of open wounds and injuries). If rashes appear after topical application, treatment should be discontinued immediately.
Do not apply to mucous membranes and eyes.
The drug contains dimethyl sulfoxide, which may cause skin irritation.
The product contains lanolin, which may cause skin reactions (e.g. contact dermatitis).
Use during pregnancy or breastfeeding
Pregnancy
Controlled clinical studies in pregnant women have not been conducted, therefore the use of indomethacin is not recommended during pregnancy.
Breast-feeding
Excreted in small amounts into breast milk, as a result of which it is not recommended for use in women during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect the ability to drive vehicles or operate other mechanisms.
Method of administration and doses
Method of application: topically, on the skin.
Apply the ointment to the affected area 3-4 times a day, gently rubbing into the skin until it is completely absorbed. The amount of ointment required for one application depends on the area of the lesion and is approximately 4-5 cm. Apply at least every 6 hours.
It is recommended to use topical forms of indomethacin in complex treatment with tablet forms.
Duration of treatment is 7-10 days. If there is no effect on symptoms during this period, treatment should be reviewed.
Children
Use for children over 14 years of age.
Overdose
With topical application, overdose is unlikely due to poor systemic absorption.
Overdose phenomena (mainly from the digestive tract, hepatotoxicity) can be observed very rarely, only with prolonged application to large skin surfaces.
It is necessary to monitor the leukocyte and platelet counts.
Symptoms of accidental ingestion: burning of the oral mucosa, salivation, nausea, vomiting.
Treatment: rinsing the mouth and stomach, if necessary - symptomatic treatment.
There is no specific antidote.
Symptoms of contact with eyes, mucous membranes, or open wounds: local irritation is observed - tearing, redness, burning, pain.
Treatment: abundant washing of the affected area with distilled water or saline until the complaints decrease and disappear.
Adverse reactions
Adverse reactions are related to the method of administration.
The likelihood of systemic side effects with topical use of indomethacin is insignificant compared to the frequency of adverse reactions with oral use.
On the part of the immune system
Local edema and vesicular rash rarely develop, and in some cases, angioedema and suffocation.
Gastrointestinal tract
When applied to a large surface of the skin, resorptive adverse reactions may occur, for example, gastrointestinal disorders (loss of appetite, nausea, vomiting, diarrhea, pain, hemorrhages and ulcers), increased levels of liver enzymes.
Skin and subcutaneous tissue disorders
Sometimes, with topical application, susceptible patients may experience burning at the site of application, redness, itching, rash, peeling, and dry skin.
In such cases, the use of the drug should be discontinued.
Expiration date
3 years.
The shelf life after opening the tube is 1 month.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
40 g of ointment in aluminum tubes with a membrane; 1 tube in a cardboard pack.
When using the tube for the first time, you must punch a hole in the aluminum foil!
Vacation category
Without a prescription.
Producer
JSC "Sopharma", Bulgaria.
Location of the manufacturer and its business address
Permission to release the series:
JSC "Sopharma".
16 Ilienskoe Shose St., Sofia, 1220, Bulgaria.
