USES OF ACTIDE 100MCG INJECTION

ACTIDE 100MCG INJECTION is used to:

• Treat acromegaly
• Treat neuroendocrine tumors in the gut (Ex. appendix, small intestine or colon)
• Treat pituitary tumors that make too much thyroid-stimulating hormone (TSH)
• Prevent complications after surgery of the pancreas
• To relieve symptoms associated with excess production of certain hormones and other related substances by the stomach, bowels or pancreas
• Stop bleeding and protect from re-bleeding from ruptured gastro-esophageal veins in patients suffering from cirrhosis

HOW ACTIDE 100MCG INJECTION WORKS

ACTIDE 100MCG INJECTION relieves the symptoms of acromegaly and overproduction of other hormones by inhibiting the release of certain hormones such as growth hormone and also by reducing the size of pituitary gland (which is enlarged in acromegaly). ACTIDE 100MCG INJECTION also helps to control bleeding and reduce transfusion requirements in patients with ruptured gastro-oesophageal varices.

DIRECTIONS FOR USE

ACTIDE 100MCG INJECTION will be given to you only by a doctor or a nurse into upper arms, thighs or abdomen as a subcutaneous injection. The correct dose and duration of ACTIDE 100MCG INJECTION treatment will be decided by your doctor for you depending on your age, body weight and disease condition.

SIDE EFFECTS OF ACTIDE 100MCG INJECTION

COMMON

• Gallstones (causing sudden back pain)
• Excess or low blood sugar
• Hypothyroidism (underactive thyroid gland which causes changes in heart rate, appetite or weight, tiredness, feeling cold or swelling at the front of the neck)
• Changes in thyroid function tests
• Cholecystitis (inflammation of the gallbladder causing pain in the upper right abdomen, fever, nausea, yellowing of the skin and eyes)
• Impaired glucose tolerance
• Slow heartbeat
• Diarrhoea, stomach pain, nausea, constipation, wind, loss of appetite
• Headache, dizziness
• Local pain at the injection site
• Stomach discomfort after meal, vomiting, feeling full
• Fatty or loose stools, discolored faeces
• Change in liver function tests
• Hair loss
• Shortness of breath
• Weakness

UNCOMMON

• Feeling thirsty, dark urine, low urine output, dry flushed skin
• Fast heartbeat

RARE

• Acute bowel obstruction, with progressive abdominal swelling, severe upper stomach pain, tender stomach and stomach contractions

Stop receiving ACTIDE 100MCG INJECTION and contact your doctor immediately if you experience any of the following side effects:

• Hypersensitivity (allergic) reactions including skin rash
• Anaphylaxis (a type of allergic reaction which can cause difficulty in swallowing or breathing, swelling and tingling, possibly with a drop in blood pressure with dizziness)
• Pancreatitis (inflammation of the pancreas causing sudden pain in the upper abdomen, nausea, vomiting, diarrhea)
• Hepatitis (liver inflammation causing yellowing of the skin and eyes, nausea, vomiting, loss of appetite, generally feeling unwell, itching, light-colored urine)
• Irregular heart heartbeat
• Low level of blood platelet (increased bleeding or bruising)

HOW TO MANAGE SIDE EFFECTS

Nausea or Vomiting:

Stick to simple meals and avoid oily or spicy foods, sugary snacks and aerated drinks. Avoid drinking too much liquid or water together with your meals and slowly drink in between meals. If symptoms persist, contact your doctor.

Diarrhea:

Keep yourself hydrated by drinking lots of fluids, such as water or fruit juice. Do not consume any medicine on your own without consulting your doctor. If symptom persists, contact your doctor.

Stomach pain:

Try to rest and relax. Eat and drink slowly or try to have lesser and very frequent meals. Keep a heating pad on your stomach. If symptom persists, contact your doctor.

WARNING & PRECAUTIONS

PREGNANCY

ACTIDE 100MCG INJECTION should be used in pregnant women only if considered clearly necessary. Women of child-bearing capability should use an effective contraceptive method during treatment. Consult your doctor before receiving it.

BREASTFEEDING

ACTIDE 100MCG INJECTION is not recommended for use in breastfeeding women as it may pass through breast milk. Consult your doctor before receiving it.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you experience headache or tiredness after receiving ACTIDE 100MCG INJECTION.

KIDNEY

Dose adjustment of ACTIDE 100MCG INJECTION is required in patients with kidney impairment or those with kidney failure requiring dialysis. Consult your doctor before receiving it.

LIVER

ACTIDE 100MCG INJECTION should be used with caution in patients having liver cirrhosis. Consult your doctor before receiving it.

ALLERGY

Do not receive ACTIDE 100MCG INJECTION if you are allergic to octreotide or any of the other ingredients of this medicine.

OTHERS

Before receiving ACTIDE 100MCG INJECTION, inform your physician if you have:

• Or had gallstones at present or have had them in the past
• Diabetes
• A history of vitamin B12 deficiency

Use in pediatrics:

There is little experience with the use of ACTIDE 100MCG INJECTION in children so, consult your child’s doctor for advice.

Use in geriatrics:

ACTIDE 100MCG INJECTION should be used with caution in elderly patients. Consult your doctor before receiving it.

INTERACTIONS

A. Drug-Drug interactions:

Before receiving ACTIDE 100MCG INJECTION, inform your doctor if you are taking any of the following medicines:

• Medicines used as immunosuppressants (Ex. ciclosporin)
• Bromocriptine (used to treat Parkinson’s disease)
• Medicines used to treat heart rhythm problems (Ex. quinidine)
• Medicines used to relieve allergies (Ex. terfenadine)
• Medicines used to control blood pressure (Ex. amlodipine, atenolol)
• Medicines used to control body fluid and electrolyte balance (Ex. furosemide, spironolactone)
• Insulin (used to treat diabetes)
• Cimetidine (used to reduce acidity)
• Lutetium (177Lu) oxodotreotide (radiotherapy used for treatment of certain tumors)

Overdosage:

ACTIDE 100MCG INJECTION will be administered to you only by a doctor or a nurse in a hospital and so it is unlikely to receive an overdose. However, call your physician or nurse if you experience any unusual symptoms.

SYNOPSIS

Drug

:  

Octreotide

Pharmacological Category

:  

Octapeptides

Therapeutic Indication

:  

Acromegaly, Gut and pituitary tumors, to prevent complications after pancreatic surgery of the pancreas, to control bleeding from ruptured gastro-esophageal varices

Dosage Forms

:  

Injection

MORE INFORMATION

• Keep ACTIDE 100MCG INJECTION out of reach of children
• Store ACTIDE 100MCG INJECTION in a refrigerator at 2-8°C