PHARMACOLOGICAL CLASSIFICATION: Category A, 2.9 Special analgesic combinations
PHARMACOLOGICAL ACTION: EQUAGESIC* contains two analgesics (acetylsalicylic acid and ethoheptazine) and meprobamate which has muscle relaxant activity with a complementary anxiolytic effect.
INDICATIONS: Relief of tension headache, painful musculo-skeletal disorders complicated by mental tension and muscle spasm, painful conditions complicated, by apprehension, e.g. dysmenorrhoea. The effectiveness of EQUAGESIC* in long-term use; that is, more than 4 months, has not been assessed by systematic clinical studies. The doctor should reassess periodically the usefulness of the drug for the individual patient.
CONTRA-INDICATIONS: EQUAGESIC* is contra-indicated in patients with a history of sensitivity or severe intolerance to acetylsalicylic acid, meprobamate or ethoheptazine citrate.
WARNINGS: Do not use continuously for more than 10 days without consulting a doctor.
Aspirin (acetylsalicylic acid) has been implicated in Reyes syndrome, a rare but serious illness in children and teenagers with chicken pox and/or influenza. A doctor should be consulted before aspirin is used in such patients.
This product contains F.D. and C Yellow No 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of tartrazine-sensitivity in the general population is currently thought to be low, it is frequently seen in patients who also have aspirin-sensitivity.
DOSAGE AND DIRECTIONS FOR USE: Usual adult dosage is 2 tablets three to four times daily.
The usual dose for children 6 to 12 years of age is 1 tablet three to four times daily. Not recommended for children under 6 years.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Serious side effects have not been observed following the administration of EQUAGESIC*. A small percentage of patients may experience nausea with or without vomiting and epigastric distress. Dizziness occurs but rarely when EQUAGESIC* is administered in the recommended dosage. The meprobamate may cause drowsiness but, as a rule, this disappears as the therapy is continued. Should drowsiness persist, this symptom can usually be controlled by decreasing the dose.
On rare occasions, meprobamate has caused severe allergic reactions. This has occurred in most instances in patients who have had only 1 to 4 doses of meprobamate and have not had previous contact with the drug. Previous history of allergy does not appear to be related to the incidence of reactions. Mild reactions are characterized by an itchy urticarial or erythematous, maculopapular rash which may be generalized or confined to the groins. Acute nonthrombocytopenic purpura with cutaneous petechiae, ecchymoses, peripheral oedema and fever have also been reported. More severe cases, observed only very rarely may also have fever, fainting spells, angioneurotic oedema and bronchial spasm. Treatment consists of the administration of adrenaline, an antihistaminic and, possibly, hydrocortisone or similar agents. Meprobamate should be stopped and reinstitution of therapy should not be attempted. PRECAUTIONS: Preparations containing acetylsalicylic acid should be kept out of reach of children.
Careful supervision of dose and amounts prescribed for patients is advised, especially with those patients with a known propensity for taking excessive quantities of drugs.
Excessive and prolonged use of meprobamate in susceptible persons, for example, alcoholics, former addicts, and other severe psychoneurotics, has been reported to result in dependence on the drug. Where excessive dosage has continued for weeks or months, dosage should be reduced gradually rather than abruptly stopped since withdrawal may precipitate reactions of greater proportions than that for which the drug was originally prescribed. Abrupt discontinuation of doses in excess of the recommended dose has resulted in some cases in the occurrence of epileptiform seizures. Tolerance to alcohol is reduced. Usage in pregnancy and lactation: An increased risk of congenital malformations associated with use of minor tranquillizers (meprobamate, chlordiazepoxide, and diazepam) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.
Meprobamate passes the placental barrier. It is present both in umbilical-cord blood at or near maternal plasma levels and in, breast milk of lactating mothers at concentrations two to four times that of maternal plasma. When use of meprobamate is contemplated in breastfeeding patients the drugs higher concentrations in breast milk as compared to maternal plasma levels should be considered.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: General supportive measures should be employed along with gastric lavage. IV fluids should be administered and an adequate airway maintained.
CONDITIONS OF REGISTRATION: To be imposed by the Council.
IDENTIFICATION: EQUAGESIC* tablets are three layered: the upper layer is yellow and imprinted with WYETHthe middle layer is white and the lower layer is pink and smooth.
PRESENTATION: Bottles of 25 tablets.
STORAGE DIRECTIONS: Store in a cool (below 25°C), dry place.
Keep out of reach of children.
REFERENCE NUMBER: B 1342 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF APPLICANT: AKROMED PRODUCTS (PTY) LTD.
(Co. Reg. no. 05/13586/07)
Electron Avenue, ISANDO 1600
* Registered Trademark.
* Under licence from
WYETH-AYERST LABORATORIES, U.S.A.
DATE OF THIS PUBLICATION OF THIS PACKAGE INSERT: 20 August 1986
Davbar Dbn. 204-525
Current: January 2005
Source: Pharmaceutical Industry