OCTREOTIDE  solution for injection/infusion 

What Octreotide is used for:

Octreotide is a synthetic compound derived from somatostatin; a substance normally found in the human body which inhibits the effects of certain hormones such as growth hormone. The advantages of Octreotide over somatostatin are that it is stronger and its effects last longer. 

Octreotide is used:

• in acromegaly, a condition where the body produces too much growth hormone. 

• to relieve symptoms associated with some tumors of the gastrointestinal tract. 

• to prevent complications following surgery of the pancreas gland. 

• to stop bleeding and to protect from re-bleeding from ruptured gastro-esophageal varices in patients suffering from cirrhosis.

• to treat pituitary tumors that produce too much thyroid-stimulating hormone. 

Do not use Octreotide: 

• if you are allergic to octreotide or any of the other ingredients of this medicine.

Warnings and precautions:

Talk to your doctor before using Octreotide: 

• if you know that you have gallstones now, or have had them in the past; tell your doctor, as prolonged use of Octreotide may result in gallstone formation. Your doctor may wish to check your gallbladder periodically. 

• if you have problems with your blood sugar levels, either too high or too low. When Octreotide is used to treat bleeding from gastro-esophageal varices; monitoring of blood sugar level is mandatory. 

• if you have a history of vitamin B12 deprivation your doctor may wish to check your vitamin B12 level periodically. 

If you receive treatment with Octreotide over a long period of time, your doctor may wish to check your thyroid function periodically. Your doctor will check your liver function.

Possible side effects:

Like all medicines this medicine can cause side effects, although not everybody gets them. Some side effects could be serious. Tell your doctor straight away if you get any of the following:

• Gallstones, leading to sudden back pain

• Too much or too little sugar in the blood

• Underactive thyroid gland causing changes in heart rate, appetite or weight; tiredness, feeling cold, or swelling at the front of the neck

• Inflammation of the gallbladder; symptoms may include pain in the upper right abdomen, fever, nausea, yellowing of the skin and eyes

• Thirst, low urine output, dark urine, dry flushed skin

• Irregular heartbeat. 

• Hypersensitivity reactions including skin rash

• A type of an allergic reaction (anaphylaxis) which can cause difficulty in swallowing or breathing, swelling and tingling, possibly with a drop in blood pressure with dizziness or loss of consciousness. 

• An inflammation of the pancreas gland; symptoms may include sudden pain in the upper abdomen, nausea, vomiting, diarrhea.

• Liver inflammation; symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, generally feeling unwell, itching, light-colored urine. 

• Low level of platelet count in blood; this could result in increased bleeding or bruising.  

Other medicines and Octreotide:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You can generally continue taking other medicines while on Octreotide. However, certain medicines, such as cimetidine, ciclosporin, bromocriptine, quinidine and terfenadine have been reported to be affected by Octreotide. 

If you are taking a medicine to control your blood pressure or an agent to control your fluid and electrolyte balance, your doctor may need to adjust the dosage. If you are diabetic, your doctor may need to adjust your insulin dosage.

How to use Octreotide:

Depending on the condition being treated, Octreotide is given by: subcutaneous injection or intravenous infusion. 

The upper arms, thighs, and abdomen are good areas for subcutaneous injection. Choose a new site for each subcutaneous injection so that you do not irritate a particular area. Patients who will be injecting themselves must receive precise instructions from the doctor or nurse. If you store the medicine in the refrigerator, it is recommended that you allow it to reach room temperature before using it. This will reduce the risk of pain at the site of injection. You can warm it up in your hand but do not heat it. A few people experience pain at the site of the subcutaneous injection. This pain usually only lasts a short time. If this happens to you, you can relieve this by gently rubbing the site of injection for a few seconds afterwards. Before using an Octreotide ampoule, check the solution for particles or a change of color. Do not use it if you see anything unusual.

How to store Octreotide:

• Keep this medicine out of the sight and reach of children. Store in the original package in order to protect from light. Store in a refrigerator (2°C to 8°C). Do not freeze. 

• The ampoules (50, 100 and 500 micrograms/1ml) may be stored below 30°C for up to two weeks.

• The ampoules should be used immediately after opening. 

• Diluted solutions should be used immediately after preparation. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. 

• Do not use this medicine if you notice particles or a change of color.