Medicinal Products

DICLOFENAC G GAM 75 mg / 3 ml

Generic drug from Voltarene
Therapeutic class: Anti-inflammatories
Active ingredients: Diclofenac
laboratory: Ggam

IM Injectable Solution
Box of 2 self-breaking ampoules of 3 ml
All forms

Indication

They come from the anti-inflammatory activity of diclofenac, 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 the adult and the child from 15 years, to the short-term symptomatic treatment of:
- inflammatory rheumatism in thrust,
- acute low back pain,
- radiculalgia,
- renal colic attacks.

Dosage DICLOFENAC G GAM 75 mg / 3 ml Solution for injection IM Box of 2 self-breaking ampoules of 3 ml

Intramuscular route.
Administration mode :
Injections should be done in a strictly aseptic manner in the outer part of the supero-outer quadrant of the buttock, deeply and slowly. When repeated, it is recommended to change sides at each injection. It is important to aspirate before injecting, to make sure that the tip of the needle is not in a vessel.
In case of severe pain at the time of injection, stop it immediately.
In the case of a hip prosthesis, the injection must be made on the opposite side.
Dosage:
1 ampoule at 75 mg per day in a single injection. Treatment may be supplemented, if necessary, with a 50 mg diclofenac tablet.
Duration of administration:
The duration of treatment is 2 to 3 days (this time allowing if necessary the implementation of the therapeutic relay orally or rectally).
Diclofenac Injection is only given when the oral or rectal route can not be used.

Against indications

CONTRAINDICATED:
This medicine is contraindicated in the following cases:
- history of allergy or asthma triggered by taking diclofenac or substances of similar activity such as other NSAIDs, aspirin,
- evolving gastroduodenal ulcer,
- severe hepatocellular insufficiency,
- severe renal insufficiency,
- child under 15,
- hemostasis disorders or ongoing anticoagulant therapy (contraindication related to the intramuscular route).
- 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 possible lengthening of the 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.
- This drug is generally not recommended in combination with:
. other NSAIDs (including high-dose salicylates),
. heparins (parenteral route),
. lithium,
. methotrexate (used at doses greater than 15 mg / week),
. ticlopidine.

Side effects Diclofenac G Gam

- Gastrointestinal effects:
. Uncommon : at the start of treatment, nausea, vomiting, diarrhea, abdominal cramps, epigastric pain, dyspepsia, anorexia, belching.
. Rare : gastroduodenal ulcer, perforation or digestive hemorrhage. These are all the more frequent as the dosage used is high.
. Isolated cases : lower abdominal conditions such as nonspecific haemorrhagic colitis, exacerbation of ulcerative colitis. Pancreatitis has been reported, cases of constipation.
- Skin effects:
. Isolated cases : hair loss, photosensitization reactions.
. Very rare : occurrence of bullous dermatoses (Stevens-Johnson, Lyell's syndrome) and erythroderma
- Hypersensitivity reactions:
. dermatological : rash, urticaria, eczema.
. Respiratory : bronchospasm, hypersensitivity pneumonitis.
. others : isolated cases of vasculitis, including allergic purpura, hypotension.
. general : very rare anaphylactic / anaphylactoid reactions, especially in subjects with allergy to aspirin.
- Effects on the central nervous system:
. Uncommon : Headache, dizziness or vertigo.
. Rarely : drowsiness.
. Isolated cases : convulsions, aseptic meningitis. Insomnia, irritability, asthenia, tremors have been reported.
Isolated cases of sensory disturbances: paresthesia, visual disturbances (visual blur, diplopia), tinnitus.
- Effects on the kidney:
. Rare peripheral edema.
. Isolated cases : acute renal failure, urinary abnormalities (hematuria, proteinuria), interstitial nephritis, nephrotic syndrome, papillary necrosis, hyperkalemia due to hyporeninism.
- Effects on the liver:
. Uncommon : increased serum transaminases.
. Rare hepatitis with or without jaundice.
. Isolated cases : fulminant hepatitis.
- Effects on the blood:
Very rarely, leukopenia, agranulocytosis, thrombocytopenia with or without purpura, medullary aplasia, hemolytic anemia.
- Effects related to the form:
. Uncommon : pain and induration at the injection site;
. Isolated cases : abscess and necrosis at the injection site.

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