Octreotide (Oral)

Generic name: Octreotide
Drug class: Somatostatin and somatostatin analogs

Usage of Octreotide (Oral)

Octreotide is used for the long-term treatment of acromegaly (a growth hormone disorder) in patients who have been previously treated with octreotide or lanreotide. This medicine works by reducing the amount of growth hormone that the body produces.

This medicine is available only with your doctor's prescription.

Octreotide (Oral) side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bladder pain

bloody or cloudy urine

blurred vision

chest tightness

chills

cough

diarrhea

difficult, burning, or painful urination

dry mouth

fever

flushed, dry skin

frequent urge to urinate

fruit-like breath odor

gaseous stomach pain

general feeling of discomfort or illness

headache

increased hunger

increased thirst

increased urination

joint pain

loss of appetite

lower back or side pain

muscle aches or pains

nausea

pain or tenderness around the eyes and cheekbones

recurrent fever

shivering

sore throat

stomach pain or fullness

stuffy or runny nose

sweating

swelling of the hands, ankles, feet, or lower legs

trouble breathing

trouble sleeping

unexplained weight loss

unusual tiredness or weakness

vomiting

yellow eyes or skin

Less common

Anxiety

body aches or pain

burning feeling in the chest or stomach

cold sweats

confusion

constipation

cool, pale skin

depressed mood

dizziness

dry skin and hair

ear congestion

fainting

fast, slow, or irregular heartbeat

hair loss

hoarseness or husky voice

indigestion

loss of consciousness

loss of voice

muscle cramps or stiffness

nervousness

nightmares

pounding in the ears

seizures

shakiness

slurred speech

sneezing

stomach upset or tenderness

weight gain

Incidence not known

Black, tarry stools

bleeding gums

blindness

bloating

blood in vomit

change in the frequency or amount of urine

changes in vision

chest pain or discomfort

dark urine

darkening of the skin

deafness

decreased vision

dizziness, fainting, or lightheadedness when getting up suddenly from lying or sitting position

double vision

eye pain

hives, skin rash

itching, pain, redness, swelling, tenderness, or warmth of the skin

light-colored stools

loss of appetite

migraine headache

pain or discomfort in the arms, jaw, back, or neck

pale skin

paleness or cold feeling in the fingertips and toes

pinpoint red spots on the skin

problems with speech or speaking

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

severe cramping

sores, ulcers, or white spots on the lips or in the mouth

tearing

tingling or pain in the fingers or toes when exposed to cold temperature

unusual bleeding or bruising

vomiting of blood or material that looks like coffee grounds

weakness of the muscles in your face

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty in moving

joint swelling or redness

lack or loss of strength

passing gas

pressure in the stomach

swelling of the abdominal or stomach area

Less common

Bleeding after defecation

uncomfortable swelling around the anus

Incidence not known

Decreased interest in sexual intercourse

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

swelling of the breasts or breast soreness in both females and males

unexpected or excess milk flow from breasts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Octreotide (Oral)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever HAD any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of octreotide in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of octreotide in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil

Cisapride

Dronedarone

Levoketoconazole

Levomethadyl

Mesoridazine

Pimozide

Piperaquine

Saquinavir

Sparfloxacin

Terfenadine

Thioridazine

Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acarbose

Acecainide

Acetophenazine

Adagrasib

Ajmaline

Albiglutide

Alfentanil

Alogliptin

Aluminum Carbonate, Basic

Aluminum Hydroxide

Aluminum Phosphate

Amiodarone

Amisulpride

Amitriptyline

Amoxapine

Anagrelide

Apomorphine

Aprindine

Aripiprazole

Aripiprazole Lauroxil

Arsenic Trioxide

Asenapine

Astemizole

Atazanavir

Azimilide

Azithromycin

Bretylium

Buprenorphine

Buserelin

Calcium Carbonate

Calcium Silicate

Canagliflozin

Ceritinib

Chloral Hydrate

Chloroquine

Chlorpromazine

Chlorpropamide

Cimetidine

Ciprofloxacin

Citalopram

Clarithromycin

Clofazimine

Clomipramine

Clothiapine

Clozapine

Copper Cu 64 Dotatate

Crizotinib

Cyclosporine

Dabrafenib

Dapagliflozin

Dasatinib

Degarelix

Delamanid

Desipramine

Deslorelin

Desogestrel

Deutetrabenazine

Dexlansoprazole

Dexmedetomidine

Dibenzepin

Dienogest

Digoxin

Dihydroergotamine

Dihydroxyaluminum Aminoacetate

Dihydroxyaluminum Sodium Carbonate

Disopyramide

Dofetilide

Dolasetron

Domperidone

Donepezil

Doxepin

Droperidol

Drospirenone

Dulaglutide

Efavirenz

Empagliflozin

Encainide

Encorafenib

Enflurane

Entrectinib

Ergotamine

Ertugliflozin

Erythromycin

Escitalopram

Esomeprazole

Estradiol

Ethinyl Estradiol

Ethopropazine

Ethynodiol

Etrasimod

Exenatide

Famotidine

Fentanyl

Fexinidazole

Fingolimod

Flecainide

Flibanserin

Fluconazole

Fluoxetine

Fluphenazine

Formoterol

Foscarnet

Fostemsavir

Gallium ga 68 dotatate

Gallium ga 68 dotatoc

Gatifloxacin

Gemifloxacin

Gepirone

Gestodene

Glasdegib

Glimepiride

Glipizide

Glyburide

Gonadorelin

Goserelin

Granisetron

Halofantrine

Haloperidol

Halothane

Histrelin

Hydroquinidine

Hydroxychloroquine

Hydroxyzine

ibutilide

Iloperidone

Imipramine

Inotuzumab Ozogamicin

Insulin

Insulin Aspart, Recombinant

Insulin Bovine

Insulin Degludec

Insulin Detemir

Insulin Glargine, Recombinant

Insulin Glulisine

Insulin Lispro, Recombinant

Isoflurane

Isradipine

Ivabradine

Ivosidenib

Ketoconazole

Lansoprazole

Lapatinib

Lefamulin

Lenvatinib

Leuprolide

Levofloxacin

Levonorgestrel

Lidoflazine

Linagliptin

Liraglutide

Lixisenatide

Lofexidine

Lopinavir

Lorcainide

Lumefantrine

Lutetium Lu 177 Dotatate

Macimorelin

Magaldrate

Magnesium Carbonate

Magnesium hydroxide

Magnesium oxide

Magnesium Peroxide

Magnesium Trisilicate

Mefloquine

Mestranol

Metformin

Methadone

Methotrimeprazine

Metronidazole

Mifepristone

Miglitol

Mirtazapine

Mobocertinib

Moxifloxacin

Nafarelin

Nateglinide

Nilotinib

Nizatidine

Nomegestrol

Norethindrone

Norfloxacin

Norgestimate

Norgestrel

Nortriptyline

Ofloxacin

Olanzapine

Omeprazole

Ondansetron

Osilodrostat

Osimertinib

Oxaliplatin

Oxycodone

Ozanimod

Pacritinib

Paliperidone

Panobinostat

Pantoprazole

Paroxetine

Pasireotide

Pazopanib

Pentamidine

Perphenazine

Phenobarbital

Pimavanserin

Pioglitazone

Pipotiazine

Pirmenol

Pitolisant

Ponesimod

Posaconazole

Prajmaline

Pramlintide

Primidone

Probucol

Procainamide

Prochlorperazine

Promazine

Promethazine

Propafenone

Propiomazine

Protriptyline

Quetiapine

Quinidine

Quinine

Quizartinib

Rabeprazole

Ranitidine

Ranitidine Bismuth Citrate

Ranolazine

Relugolix

Repaglinide

Ribociclib

Risperidone

Rosiglitazone

Roxatidine

Saxagliptin

Selpercatinib

Sematilide

Sertindole

Sertraline

Sevoflurane

Siponimod

Sirolimus

Sitagliptin

Sodium BIcarbonate

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

SolifeNACin

Sorafenib

Sotalol

Spiramycin

Sulfamethoxazole

Sulpiride

Sultopride

Sunitinib

Tacrolimus

Tedisamil

Telavancin

Telithromycin

Temsirolimus

Tetrabenazine

Thiethylperazine

Tolazamide

Tolbutamide

Toremifene

Trazodone

Triclabendazole

Trifluoperazine

Triflupromazine

Trimeprazine

Trimethoprim

Trimipramine

Triptorelin

Vandetanib

Vardenafil

Vemurafenib

Vilanterol

Vildagliptin

Vinflunine

Voclosporin

Voriconazole

Zolmitriptan

Zotepine

Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Lisinopril

Pegvisomant

Telotristat Ethyl

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Relate drugs

How to use Octreotide (Oral)

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take this medicine with a glass of water on an empty stomach, at least 1 hour before or at least 2 hours after a meal.

Swallow the delayed-release capsule whole. Do not crush, break, or chew it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (delayed-release capsules):

For acromegaly:

Adults—At first, 20 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 80 mg per day.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

You may keep the opened medicine at room temperature for up to 1 month. Throw away any unused medicine after 1 month.

Warnings

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may increase your risk of having gallstones (cholelithiasis), which may lead to swelling of the gallbladder (cholecystitis), bile ducts (cholangitis), or pancreas (pancreatitis). Check with your doctor right away if you have severe stomach pain with nausea and vomiting, indigestion, fever, chills, pains in the stomach or side, possibly radiating to the back, fast heartbeat, dark urine, bloating, or yellow eyes or skin.

This medicine may cause your blood sugar levels to rise or fall. It may cover up signs of hypoglycemia (low blood sugar), such as a change in your pulse rate. If you notice a change in the results of your blood sugar or urine sugar test, check with your doctor.

Octreotide may cause hypothyroidism (underactive thyroid gland). Check with your doctor right away if you have constipation, a depressed mood, dry skin and hair, cold skin, hair loss, hoarseness or husky voice, muscle cramps and stiffness, a slow heartbeat, weight gain, or unusual tiredness or weakness.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, slow, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.

This medicine may cause a serious allergic reaction, called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may improve fertility in some women, which could increase the risk for unplanned pregnancies. Talk to your doctor if you have any concerns.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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