Octreotide (Oral route)

Pronunciation:

ok-TREE-oh-tide AS-e-tate

Brand Names:

Mycapssa

Dosage Forms:

Capsule, Delayed Release

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Octreotide

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

Other 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
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

Other interactions—

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Diabetes or
Gallbladder disease or
Heart rhythm problems or
Thyroid problems or
Vitamin B12 deficiency—Use with caution. May make these conditions worse.

End-stage kidney disease or
Liver disease (eg, cirrhosis, fatty liver disease)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

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.

Last Updated: 11/16/2023

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