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Voren Suppositories
Ingredient(s):
Voren Suppositories 12.5mg:
Each supp. contains:
Diclofenac Sodium ..........12.5mg
Voren Suppositories 25mg:
Each supp. contains:
Diclofenac Sodium .......... 25mg
Voren Suppositories 50mg:
Each supp. contains:
Diclofenac Sodium .......... 50mg
Pharmacology (Summary of Pharmacodynamic and Pharmacokinetics)
1. Diclofenac is a potent non-steroidal anti-inflammatory (NSAID) with
analgesic and antipyretic properties. It also has some uricosuric effect.
Diclofenac inhibits cyclo-oxygenase activity with a reduction in the tissue
production of prostaglandins such as Prostaglandin F2a and Prostaglandin E2.
The anti-inflammatory effect, measured in the adjuvant-induced arthritis
model, is greater than that of aspirin and similar to indomenthacin.
Diclofenac causes gastric erosions and prolongs the bleeding time.
2. Although Diclofenac Sodium does not alter the cause of the underlying
disease, it has been found to relieve pain, reduce fever, swelling, and
tenderness, and increase mobility in patients with rheumatic of the types
indicated.
3. The rectally administered Diclofenac Sodium is rapidly and almost
completely absorbed and distributed to blood, liver and kidneys. The plasma
concentration shows a linear relationship to the amount of drug
administered.
4. The plasma AUC values for unchanged Diclofenac Sodium following rectal
administration are within the same range as those of the oral doses of
enteric coated tablets.
Indication(s)
Chronic rheumatic arthritis, degenerative osteoarthritis and painful
postoperative inflammation.
Dosage and Administration
Adult: 100mg, usually to be used at night. Maximum total daily dose is
150mg.
Children: 0.5-2mg/kg body weight daily, in 2-3 divided doses.
To be
inserted deep into the rectum.
To be dispensed by the physician's prescription.
After assessing the risk/ benefit ratio in each individual patient, the
lowest effective dose for the shortest possible duration should be used.
Contraindication(s)
1. Voren suppository should not be used in patients who have shown
hypersensitivity to Diclofenac Sodium.
2. It is contraindicated in patients with any inflammatory lesions of the
rectum or anus, and in patients with recent history of rectal and anal
bleeding.
3. It should not be given to children under 12 months of age.
4. It is contraindicated in patients with active or suspected peptic ulcer
or gastric-intestinal bleeding.
5. It is contraindicated in patients in whom attack of asthma, urticaria or
acute rhinitis are precipitated by aspirin or other NSAIDs.
Side Effect(s) / Adverse Reaction(s)
Local irritation; itching, burning and increased bowel movement.
Central
nervous system : dizziness, headache, insomnia, drowsiness
Hematologic system : hemolytic anemia, aplastic anemia, agranulocytosis.
Dermatologic system : rash, pruritis, skin eruptions, eczema, urticaria
and erythema.
Hepatic : jaundice, hepatitis
Ophthalmological : blurred vision.
Allergic : hypersensitivity reaction.
Precaution(s)/Warning(s)
1. Caution should be exercised in patients with a history of blood
dyscrasias or disorders of coagulation.
2. Observational studies have indicated that non-selective NSAIDs may be
associated with an increased risk of serious cardiovascular events,
principally myocardial infarction, which may increase with dose or duration
of use. Patients with cardiovascular disease or cardiovascular risk of an
adverse cardiovascular event in patient taking NSAID, especially in those
with cardiovascular risk factors, the lowest effective dose should be used
for the shortest possible duration. There is no consistent evidence that the
concurrent use of aspirin mitigates the possible increased risk of serious
cardiovascular thrombotic events associated with NSAID use.
3. NSAIDs may lead to the onset of new hypertension or worsening the
pre-existing hypertension and patients taking anti-hypertensive with NSAIDs
may have an impaired anti-hypertensive response. Caution is advised when
prescribing NSAIDs to patients with hypertension. Blood pressure should be
monitored closely during initiation of NSAID treatment and at regular
intervals thereafter.
4. Fluid retention and oedema have been observed in some patients taking
NSAIDs, there caution is advised in patients with fluid retention or heart
failure.
5. All NSAIDs can cause gastrointestinal discomfort and rarely serious,
potentially fatal gastrointestinal effects such as ulcers, bleeding and
perforation which may increase with dose or duration of use, but can occur
at any time without warning. Caution is advised in patients with risk
factors for gastrointestinal events e.g. the elderly, those with a history
of serious gastrointestinal events, smoking and alcoholism. When
gastrointestinal bleeding or ulceration occurs in patients receiving NSAIDs,
the drug should be withdrawn immediately. Doctors should warn patients about
signs and symptoms of serious gastrointestinal toxicity. The concurrent use
of aspirin and NSAIDs also increases the risk of serious gastrointestinal
adverse events.
6. NSAIDs may very rarely cause serious cutaneous adverse events such as
exfoliative dermatitis, toxic epidermal necrolysis (TEN) and Stevens-Johnson
Syndrome (SJS), which can be fatal and without warning. These serious
adverse events are idiosyncratic and are independent of dose or duration of
use. Patients should be advised of the signs and symptoms of serious skin
reaction and to consult their doctor at the first appearance of a skin rash
or any other sign of hypersensitivity.
7. The anti-inflammatory, antipyretic, and analgesic effects of Voren may
mask the normal signs of infections. The physician should be alert to any
development of infection in patients receiving Voren.
8. Patients with severe hepatic, cardiac or renal insufficiency or the
elderly should be kept under close surveillance.
9. Use of diclofenac in patients with hepatic porphyria may trigger an
attack.
WARNINGS
RISK OF GI ULCERATION, BLEEDING AND PERFORATION
WITH NSAID
Serious GI toxicity such as bleeding, ulceration and perforation can occur
at any time, with or without warning symptoms, in patients treated with
NSAID therapy. Although minor upper GI problems (eg. dyspepsia) are common,
usually developing early in therapy, prescribers should remain alert for
ulceration and bleeding in patients treated with NSAIDs even in the absence
of previous GI tract symptoms.
Studies to date have not identified any subset of patients not at risk of
developing peptic ulceration and bleeding. Patients with prior history of
serious adverse events and other risk factors associated with peptic ulcer
disease (eg. alcoholism, smoking, and corticosteroid therapy) are at
increased risk. Elderly or debilitated patients seem to tolerate ulceration
or bleeding less than other individuals and account for most spontaneous
reports for fatal GI events.
Drug Interaction(s)
The drug has an affinity for
serum albumin, and may displace other drugs which are also bound to albumin.
Concomitant treatment with Potassium sparing diuretics may be associated
with increased serum Potassium level. Concomitant administration with
Aspirin is not recommended because Voren is displaced from binding site and
resulting lower plasma concentration and peak plasma levels. Concurrent
therapy with Voren and Warfarin requires close monitoring of patients to be
certain that no change in their anticoagulant dosage is required. Patients
with altered renal function should be observed for the development of the
specific toxicities of concomitant administration of Voren and Digoxin.
Methotrexate and Cyclosporine. Patients receiving oral hypoglycemic should
be observed for signs of toxicity to these drugs.
Symptoms and Treatment for
Overdosage, and Antidote(s)
Symptoms of overdose reported
have generally reflected, the renal and CNS toxicities of this medication.
More serious overdosage effects such as, acute renal failure, convulsion and
coma have been reported.
Should accidental overdosage occur, supportive and symptomatic treatment
is indicated for complication. eg. hypotension, renal failure, convulsions
and respiratory depression. Because it is firmly bound to plasma proteins,
hemodialysis and peritoneal dialysis may be of little value.
Shelf-Life
3 years from the date of
manufacture.
Storage Condition(s)
Store at temperature below 25°C.
Protect from light and moisture
Products Description(s) &
Packing(s)
Voren Suppositories 12.5 mg :
White to a pale yellow, bullet-shaped suppositories 10 supp. per strip, 10
strips per box.
Voren Suppositories 25 mg : White
to a pale yellow, bullet-shaped suppositories. 10 supp. per strip, 10 strips
per box.
Voren Suppositiores 50 mg : White
to a pale yellow, bullet-shaped suppositories. 10 supp. per strip, 10 strips
per box.
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