Sodium Oxybate 500mg/ml oral solution

Enaphage is a biguanide antidiabetic agent used for the treatment of diabetes in patients with type 2 diabetes.

COMPOSITION

Each film coated tablet of Enaphage contains Metformin Hydr chloride B.P. 500mg.

The tablets also contain maize starch, sodium starch glycollate, talc, microcrystalline cellulose, sorbitol, propyl paraben and methyl paraben, magnesium stearate as the major inactive ingredients.

PHARMACOLOGICALACTION

Enaphage acts chiefly by decreasing hepatic gluconeogenesis and increasing peripheral utilization of glucose. Enaphage functions in the presence of some endogenous insulin production.

Enaphage is slowly and incompletely absorbed from the gastrointestinal tract; the absolute bioavailability of a single500mg dose is reported to be about 50 to 60%, although this is reduced somewhat if taken with food. Once absorbed. protein binding in plasma is negligible; the drug is excreted unchanged in the urine; The plasma elimination half-life is reported to range from about 2 to 6 hours after oral doses. Metformin crosses the placenta and is distributed into breast milk in small amounts.

INDICATIONS

Enaphage is used in the treatment of people with type 2 diabetes, when diet and exercise alone cannot sufficiently control the blood sugar levels. Enaphage is used particularly in overweight patients. In adults, Enaphage can be used alone or in combination with other medicines to treat diabetes taken by mouth, or insulin. Children 10 years and over can also use Metformin on its own or together with insulin.

DOSAGEAND ADMINISTRATION

Doses are taken orally as prescribed by a doctor. As a guide,

Adults:

Usual dose: 1 Enaphage tablet (500mg Metformin Hydrochloride) 2 to 3 times daily.

Maximum dose: 6 Enaphage tablets (3g Metformin Hydrochloride) daily.

Children 10 years and over:

Usual starting dose: 1Enaphage tablet (500mg Metformin Hydrochloride) daily.

Maximum dose: 4 Enaphage tablets (2g) daily, divided into 2 or 3 doses.

After taking Enaphage for about 2 weeks, the Doctor may measure the blood sugar and adjust the dose.

Patients 65 years and over:

The Doctor determines the dose of Enaphage based on your kidney function, as kidney impairment occurrence is high in this group.

PRECAUTIONS AND CONTRAINDICATIONS

Do not take Enaphage if you are allergic (hypersensitive) to Metformin or any of the ingredients stated.

Do not take Enaphage and inform your doctor if you have:

• severe diabetes combined with ketoacidosis (too much acid in the blood)
• severe diabetes combined with onset of loss of consciousness (diabetic precoma) kidney and liver problems
• heart failure or recently had a heart attack, severe problems with your circulation or breathing difficulties
• regularly drink large amount of alcohol and if you are dehydrated

Stop taking Metformin and inform your doctor immediately if a serious condition called lactic acidosis occurs during therapy. Symptoms include vomiting, abdominal pain with muscle cramps, generally feeling very tired and unwell, difficulty in breathing. Enaphage alone may not cause blood sugar levels to reduce so much but in combination with other drugs this could occur. Signs of low blood sugar levels include weakness, dizziness, increased sweating, rapid heartbeat, vision disorders, and difficulty concentrating. Eat or drink something containing sugar if this occurs. Alcohol increases the risk of the side effect of lactic acidosis. It is therefore advisable that you refrain from consuming alcohol during Enaphage therapy. Enaphage is also not recommended in children below 10 years of age.

Pregnancy and lactation: Enaphage should not be used in pregnant and breastfeeding women unless on the advice of a doctor.

Driving and operation of machinery: Metformin by itself does not affect the ability to drive and operate nachinery. Inappropriate use nay however results in low blood glucose which may affect your reaction time. If affected, do not drive or operate machinery.

SIDE EFFECTS

Enaphage like all medicines can cause side effects. The common side effects include nausea, vomiting. diarrhea, abdominal pain and loss of appetite These complaints mainly occur at the beginning of therapy and spontaneously disappear in most cases.

Other side effects such as lactic acidosis, change in taste, itching, tiredness, weight loss, skin reddening among others is rare and should be reported immediately to the Doctor when they occur 

INTERACTIONS:

Use of Enaphage with other drugs that lower blood glucose concentrations (other antidiabetics) increase the risk of hypoglycemia, while drugs that increase blood glucose may reduce the effect of Enaphage therapy. Alcohol may increase the risk of lactic acidosis as well as of hypo glycaemia. Care should be taken if Enaphage is given with drugs that may impair renal function.

Enaphage also interacts with other drugs such as Cimetidine, antivirals such as Didanosine, Stavudine and Tenofovir as well as with anticoagulants such as Preprohormone, Salbutamol, Terbutaline and glucocorticoids.

Enaphage should be temporarily stopped for examinations using iodinated contrast media and withheld after the examination until normal renal function is confirmed, because of the risk of contrast media-induced renal impairment leading to biguanide toxicity and associated lactic acidosis.

OVERDOSAGEAND TREATMENT

If you take more Enaphage than required, immediately contact the nearest hospital. Even though an over dosage of Enaphage alone may not cause excessive reduction in blood sugar levels, it may cause over acidification of the blood with lactic acid (lactic acidosis). Symptoms include vomiting, abdominal pain with muscle cramps, generally feeling very tired and unwell, difficulty in breathing and coma may develop within hours. This may require immediate emergency admission to hospital.

STORAGE

Enaphage should be stored at a cool dry place not exceeding 30C. Keep out of reach and sight of children.

PRESENTATION

White colored film coated tablets in blisters of 10 tablets.