DOSAGE
AND ADMINISTRATION
Oral
Inflammatory and De-Generative arthritis, RA, OA, ankylosing spondylitis,
acute gout. post-operative pain dental pain, painful musculo skeletal conditions,
low back pain etc.:50mg b.i.d or t.i.d Children over 1yr: 1-3mg/kg/day in
divided doses Dysmenorrhoea: Start with 50-100mg and increase if required
upto 200mg/day. Sustained release forms: 100mg o.d.
2. THERAPEUTIC / DIAGNOSTIC CLAIMS
Diclofenac relieves the pain, tenderness, inflammation, stiffness, and swelling
caused by certain types of arthritis. It also is used to relieve menstrual
pain and pain after surgery or childbirth.
3. DESCRIPTION OF DOSAGE FORM
Anti-inflammatory analgesic often used to treat inflammation and pain arising from arthritis, gout or rheumatic disease. Normally taken orally (tablets) but also available for injection or as suppositories.
4. CONTRAINDICATIONS
Gastric
or intestinal ulcer.
Known hypersensitivity to any component of the tablet.
Hypersensitivity to aspirin or other NSAIDs.
Patients with haemorrhagic diasthesis.
Patients in whom attacks of asthma, urticaria or active rhinitis are precipitated by acetylsalicylic acid or other agents, which inhibit prostaglandin-synthetase activity.
WARNING
AND PRECAUTIONS
Suspected or confirmed gastro-intestinal ulceration e.g. peptic ulcer, ulcerative
colitis, Crohn's disease etc.
Close medical supervision is mandatory. If gastro-intestinal bleeding or perforation
occur, the drug should be withdrawn.
Asthmatics: bronchospasm has been reported with the use of NSAIDs.
Due to the importance of prostaglandins in maintaining renal blood flow, caution
is required in patients with impaired cardiac or renal function, the elderly,
patients being treated with diuretics and patients with substantial extracellular
volume depletion.
Heart
failure, hypertension or other conditions predisposing to fluid retention:
Diclofenac can cause retention of salt and water leading to oedema. Serum
electrolytes should be monitored periodically during long term therapy.
Diclofenac should be used with caution in patients suffering from liver dysfunction.
Platelet aggregation may be inhibited temporarily. Patients with haemostasis
defects should be carefully monitored.
Porphyria: Use of diclofenac should be avoided in patients with hepatic porphyria
as it may trigger an attack.
Elevation of liver enzymes: Initial elevations are reversible. However, if
they persist or worsen during prolonged therapy, diclofenac should be discontinued.
Allergic reactions: including anaphylaxis have occasionally been reported
on first exposure to diclofenac.
Prolonged treatment: Periodic blood counts are
recommended.
Use
during Pregnancy
Diclofenac should be avoided in pregnancy unless the benefits outweigh the
potential risk to the foetus. This applies particularly to the last 3 months
of pregnancy when in common with other prostaglandin syntheses inhibitors,
diclofenac may cause closure of the foetal ducts arterioles, foetal renal
impairment, inhibition of platelet aggregation and delay labour and birth.
Use
in nursing mothers
Diclofenac is detected in breast milk following doses of 50 mg every 8 hours,
but amounts are so small that no undesirable effects on the baby are likely.
Effects on ability to drive or use machinery
Diclofenac may cause some patients to become dizzy, light-headed or less alert.
Patients should be aware of their reaction to Diclofenac before driving or
using machinery.
Interaction
Lithium & Digoxin : Blood levels of lithium
and digoxin increased leading to enhanced efficacy and posible toxicity.
Diuretics : Inhibits diuretics but efficacy of
potassium sparing diuretics enhanced.
Cyclosporine : Increases nephrotoxicity of both
agents.
Hydantions : Increases serum levels resulting
in toxicity.
5.
SIDE EFFECTS
1. Headache, dizziness. Contact your doctor if
these effects are severe.
2.Nausea, abdominal pain or cramps, diarrhea or constipation, indigestion, gas. Take diclofenac with food or an antacid.
3. Do not drink alcoholic beverages. If these symptoms continue or become severe, contact your doctor.
4. If you vomit blood or have bloody diarrhea or black, tarry stools, stop taking diclofenac and contact your doctor immediately.
5.
Skin rash; ringing in the ears; swelling of the hands, feet, ankles, or lower
legs; itching.
6. TOXIC EFFECTS
Mutagenicity, Carcinogenicity and Teratogenicity
Studies of use of diclofenac in rats did not show any effect on the fertility
of adult rats nor in the pre-, peri- and postnatal development of their offspring.
No teratogenic effects were detected in mice, rats or rabbits. No mutagenic
effects were observed in in vitro or in vivo experiments. No carcinogenic
potential was detected in long term studies in rats and mice.