Medicinal Products

DOLCIDIUM G 100 mg

Generic drug of Indocid
Therapeutic class: Anti-inflammatories
Active ingredients: Indomethacin
laboratory: Smb SA

Suppository
Box of 10
All forms

Indication

They come from the anti-inflammatory activity of indomethacin, the importance of the manifestations of intolerance to which the drug gives rise and from its place in the range of anti-inflammatory products currently available.
They are limited in adults (over 15 years), to:
- long-term symptomatic treatment:
. chronic inflammatory rheumatism, including rheumatoid arthritis, ankylosing spondylitis,
. some disabling and painful arthroses.
- short-term symptomatic treatment of acute episodes of:
. abarticular rheumatism (scapulohumeral periarthritis, tendinitis, bursitis),
. microcrystalline arthritis,
. severe radiculalgia,
. arthrosis.

Dosage DOLCIDIUM GOLD 100 mg suppository Box of 10

Administration mode :
Rectal way.
The choice of the rectal route is determined solely by the convenience of administering the drug.
Wash hands after handling the suppository.
Duration of administration:
The use of the rectal route should be as short as possible because of the risk of local toxicity added to the risks of the oral route.
Dosage:
- 1 suppository of 100 mg of indomethacin per day.
- The dosage can exceptionally reach 2 suppositories (200 mg of indomethacin) per day, especially in cases of microcrystalline arthritis: 150 to 200 mg / day of indomethacin in divided doses until the crisis disappears.
- A reduction in doses should be considered in the elderly and in renal failure.

Against indications

CONTRAINDICATED:
This medicine is contraindicated in the following cases:
- history of allergy or asthma triggered by taking this drug or substances of similar activity such as other NSAIDs, aspirin,
- history of allergy to any of the excipients,
- evolving gastroduodenal ulcer,
- gastrointestinal haemorrhage,
- severe hepatocellular insufficiency,
- severe renal insufficiency,
- severe uncontrolled heart failure,
- recent history of proctitis or rectorrhagia (contraindication related to the route of administration),
- child under 15,
- from the 6th month of pregnancy: during the third trimester, all prostaglandin synthesis inhibitors may expose the fetus to cardiopulmonary toxicity (pulmonary arterial hypertension with premature closure of the ductus arteriosus), renal dysfunction up to renal failure with oligoamnios; the mother and the child, at the end of pregnancy, to a longer bleeding time. As a consequence, apart from extremely limited obstetric use and which warrant specialized supervision, the prescription of NSAIDs is contraindicated from the 6th month.
NOT RECOMMENDED :
- Breast-feeding: NSAIDs passing into breast milk, as a precaution, should be avoided in women who are breastfeeding.
- Associations advised against : other NSAIDs (including high-dose salicylates); oral anticoagulants; diflunisal; lithium; methotrexate (used at doses greater than 15 mg / week).

Side effects Dolcidium GE

Gastrointestinal effects:
- Mostly reported gastrointestinal disorders such as epigastralgia, often mild or moderate, nausea, vomiting, diarrhea, constipation; rarely, isolated or multiple ulcerations of the digestive tract sometimes cause stenosis or occlusion, gastrointestinal haemorrhage and / or perforation. These digestive haemorrhages are all the more frequent as the dosage used and elevated.
- Risk of local toxicity (related to the route of administration), all the more frequent and intense as the duration of suppository treatment is prolonged: rectal burns or irritations, pain, pruritus, tenesmus, proctitis, rectorrhagia.
- Work (using the 51 chromium-labeled red blood cell method) has shown that the digestive blood losses observed are lower on indomethacin at the oral dosage of 50 mg four times daily, than under acetylsalicylic acid at the oral dosage of 600 mg four times daily. times a day.
- Exacerbation of abdominal pain in subjects previously suffering from ulcerative colitis.
Hypersensitivity reactions:
- dermatological : skin rash, urticaria, pruritus, exfoliative dermatitis, vasculitis, erythema nodosum, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome; exceptional cases of photosensitization.
- respiratory : asthma, acute respiratory distress, pulmonary edema.
- general : Quincke's edema, anaphylactic shock.
Effects on the central nervous system:
- most often, headache, vertigo, asthenia.
- infrequently, mental confusion, syncope, somnolence, insomnia, anxiety, convulsions, coma, peripheral neuropathies, involuntary movements, muscular weakness, psychic disorders with delusions, hallucinations, psychotic episodes.
- more rarely, paresthesia, dysarthria, worsening of epilepsy and Parkinson's disease.
Most often transient or disappearing after dosage reduction, these events sometimes require the cessation of treatment.
Ocular adverse effects:
rare, with orbital and periorbital pain, diplopia, visual fog that may reveal retinal abnormalities (including macula) or corneal deposits.
Others:
- alopecia,
- renal reactions: proteinuria, elevation of creatinine, nephrotic syndrome, interstitial nephritis, sometimes acute and severe renal failure, oliguria, hematuria,
- possible mild peripheral edema in patients with compromised cardiac function;
rarely: elevation of blood pressure, tachycardia, chest pain, arrhythmia, palpitations, hypotension, congestive heart failure;
- breast changes (increased volume and sensitivity) or gynecomastia, vaginal bleeding;
- hearing impairment, rarely deafness;
- flush, sweating, fever, epistaxis.
Some biological modifications could be observed:
- haematological : leukopenia, thrombocytopenia, bone marrow suppression, bleeding anemia or haemolytic anemia;
rarely, agranulocytosis and medullary hypoplasia;
- Hepatic : rarely, biological abnormalities with jaundice and hepatitis, some deaths have been reported.
- metabolic : hyperglycemia, glycosuria, hyperkalemia.

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