Inderide (Oral)

Propranolol and hydrochlorothiazide combination is used to treat high blood pressure (hypertension). High blood pressure increases the workload of the heart and arteries. If it lasts for a long time, the heart and arteries may not work properly. This can damage the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. High blood pressure may also raise the risk of heart attacks. Controlling blood pressure may help reduce the chances of these problems.

Propranolol is a beta-blocker. It works by changing how some nerve signals affect certain parts of the body, such as the heart. This causes the heart to beat slower and lowers blood pressure. When blood pressure decreases, more blood and oxygen reach the heart.

Hydrochlorothiazide is a diuretic (water pill). It lowers the amount of water in the body by increasing urine flow, which helps lower blood pressure.

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

It is very important for your doctor to check your progress at regular appointments to ensure this medicine is working properly. Blood and urine tests may be needed to look for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical help. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, lips, tongue, or throat while using this medicine.

This medicine may cause or worsen heart failure in some patients. Check with your doctor immediately if you experience chest pain or discomfort, dilated neck veins, extreme fatigue, irregular breathing, an irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain.

Do not interrupt or stop taking this medicine without first consulting your doctor. Your doctor may want you to slowly decrease the amount you are taking before stopping it completely. Some conditions may worsen when the medicine is stopped suddenly, which can be dangerous.

This medicine may cause changes in your blood sugar levels. It may also hide signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these issues or notice a change in your blood or urine sugar test results.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

Serious skin reactions (for example, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme) can happen while using this medicine. Contact your doctor right away if you notice skin itching, swelling, rash, or redness, blistering, peeling, or loosening of the skin, or any other unusual effects that may be linked to this medicine.

Contact your doctor immediately if you experience dry mouth, increased thirst, muscle cramps, nausea or vomiting, unusual tiredness or weakness, severe drowsiness or dizziness, seizures, a decrease in urine, or a fast heartbeat while using this medicine. These may be signs of dehydration or mineral imbalance.

See your doctor right away if you have blurred vision, difficulty reading, eye pain, or any other changes in vision during or after treatment. This could indicate a serious eye problem. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may increase your risk of developing skin cancer (for example, non-melanoma skin cancer). Avoid sun exposure. Use sunscreen when outdoors. Avoid sunlamps and tanning beds. Discuss any concerns about this risk with your doctor.

Alcohol, narcotic pain relievers, or sleeping pills may make you feel more lightheaded, dizzy, or faint when taken with this medicine. Inform your doctor if you are drinking alcohol or using pain relievers or sleeping pills.

Do not take other medicines unless you have discussed them with your doctor. This is especially important for prescription or nonprescription (over-the-counter) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, as they may raise your blood pressure.

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

Allergies

Inform your clinician if you have ever had any unusual or allergic reaction to this medication 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 propranolol and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of propranolol and hydrochlorothiazide combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving propranolol and hydrochlorothiazide combination.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this drug during breastfeeding. Weigh the potential benefits against the potential chances before using this drug 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 physician may want to change the dose, or other precautions may be necessary. When you are using this medication, it is especially important that your healthcare professional know if you are taking any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this drug with any of the following medicines is not advised. Your clinician may decide not to treat you with this medicine or change some of the other drugs you take.

• Dofetilide
• Rizatriptan
• Thioridazine

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

• Abametapir
• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Albuterol
• Alogliptin
• Amphetamine
• Amtolmetin Guacil
• Arsenic Trioxide
• Aspirin
• Benzphetamine
• Bromfenac
• Bromocriptine
• Bufexamac
• Bupivacaine
• Bupivacaine Liposome
• Buprenorphine
• Bupropion
• Canagliflozin
• Capmatinib
• Celecoxib
• Ceritinib
• Chlorpropamide
• Choline Salicylate
• Clonidine
• Clonixin
• Codeine
• Crizotinib
• Dapagliflozin
• Darunavir
• Deslanoside
• Desmopressin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Diatrizoate
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Diltiazem
• Dipyrone
• Dronedarone
• Droperidol
• Droxicam
• Dulaglutide
• Empagliflozin
• Epinephrine
• Escitalopram
• Eslicarbazepine Acetate
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Fedratinib
• Felbinac
• Fenoldopam
• Fenoprofen
• Fepradinol
• Feprazone
• Fexinidazole
• Fingolimod
• Flecainide
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Formoterol
• Glimepiride
• Glipizide
• Glyburide
• Haloperidol
• Ibuprofen
• Indacaterol
• Indomethacin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Iobenguane I 131
• Iohexol
• Ketanserin
• Ketoprofen
• Ketorolac
• Lacosamide
• Lercanidipine
• Levalbuterol
• Levomethadyl
• Lidocaine
• Linagliptin
• Liraglutide
• Lisdexamfetamine
• Lithium
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Mefloquine
• Meloxicam
• Mepivacaine
• Methamphetamine
• Methotrexate
• Metildigoxin
• Miglitol
• Morniflumate
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Olodaterol
• Ouabain
• Oxaprozin
• Oxymetazoline
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Pixantrone
• Ponesimod
• Porfimer
• Pramlintide
• Prilocaine
• Proglumetacin
• Propyphenazone
• Proquazone
• Proscillaridin
• Repaglinide
• Rivastigmine
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salmeterol
• Salsalate
• Saxagliptin
• Simeprevir
• Siponimod
• Sitagliptin
• Sodium Salicylate
• Sotalol
• Sparsentan
• Sulindac
• Tapentadol
• Tenoxicam
• Terbutaline
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Valdecoxib
• Venlafaxine
• Verapamil
• Vilanterol
• Vildagliptin
• Zileuton

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

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Alfuzosin
• Alogliptin
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Aminolevulinic Acid
• Amtolmetin Guacil
• Aspirin
• Bepridil
• Bromfenac
• Bufexamac
• Bunazosin
• Calcium Carbonate
• Canagliflozin
• Carbamazepine
• Celecoxib
• Chlorpromazine
• Chlorpropamide
• Cholestyramine
• Choline Salicylate
• Cimetidine
• Clonixin
• Dapagliflozin
• Deslanoside
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Digitoxin
• Digoxin
• Dihydroergotamine
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Dipyrone
• Doxazosin
• Droxicam
• Dulaglutide
• Empagliflozin
• Ergotamine
• Ertugliflozin
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Fluvoxamine
• Ginkgo
• Glimepiride
• Glipizide
• Glyburide
• Gossypol
• Ibuprofen
• Indomethacin
• Insulin Aspart, Recombinant
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Human Inhaled
• Insulin Human Isophane (NPH)
• Insulin Human Regular
• Insulin Lispro, Recombinant
• Ketoprofen
• Ketorolac
• Licorice
• Linagliptin
• Liraglutide
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magaldrate
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Metformin
• Metildigoxin
• Miglitol
• Morniflumate
• Moxisylyte
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenoxybenzamine
• Phentolamine
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Pramlintide
• Pranoprofen
• Prazosin
• Proglumetacin
• Propyphenazone
• Proquazone
• Quinidine
• Repaglinide
• Rifapentine
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sitagliptin
• Sodium Salicylate
• St John's Wort
• Sulindac
• Tamsulosin
• Tenoxicam
• Terazosin
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Trimazosin
• Urapidil
• Valdecoxib
• Vildagliptin

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 additionally cause interactions to occur. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Tobacco

Other Medical Issues

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

• Angina (serious chest pain)—May provoke chest pain if stopped too rapidly.

• Anuria (not capable to form urine) or
• Asthma or
• Bradycardia (slow heartbeat) or
• Cardiogenic shock (shock caused by heart attack) or
• Congestive heart failure or
• Heart block or
• Sulfa drug allergy (eg, sulfamethoxazole, Bactrim®, Septra®)—Should not be used in patients with these conditions.

• Diabetes or
• Hyperthyroidism (overactive thyroid) or
• Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat.

• Electrolyte imbalance (eg, hypercalcemia, hypokalemia, hypomagnesemia, hyponatremia) or
• Glaucoma, secondary angle closure or
• Gout or
• Hyperuricemia (high uric acid in the blood) or
• Liver disease or
• Myopia, acute (changes in the eyeball causing vision issues) or
• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased since of slower removal of the medication from the body.

• Lung disease (eg, bronchitis, emphysema)—May cause difficulty with breathing in patients with this condition.

• Sympathectomy—Use with caution. The effects of this medicine may be increased.

• Wolff-Parkinson-White syndrome (rare heart condition)—May cause extremely slow heartbeat in patients with this condition.

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:

Incidence not known

• Black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine
• bloody nose
• bloody stools
• blurred or loss of vision
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain, discomfort, or tightness
• clay-colored stools
• cold sweats
• confusion about identity, place, and time
• congestion
• constipation
• cough
• coughing up blood
• cracks in the skin
• crying
• darkened urine
• decreased awareness or responsiveness
• decreased urine output
• depersonalization
• diarrhea
• difficulty with breathing or swallowing
• dilated neck veins
• disturbed color perception
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• double vision
• dry mouth
• dryness or soreness of the throat
• dysphoria
• false or unusual sense of well-being
• fast, pounding, slow, or irregular heartbeat
• fever or chills
• flushing or redness of the skin
• fruit-like breath odor
• general feeling of discomfort or illness
• general feeling of tiredness or weakness
• hair loss
• halos around lights
• headaches
• heavier menstrual periods
• hives or welts, itching
• hoarseness
• increased hunger
• increased sensitivity of the skin to sunlight
• increased thirst
• increased urination
• indigestion
• irregular breathing
• irregular heartbeat
• joint pain, stiffness, or swelling
• lightheadedness, dizziness, or fainting
• loss of appetite
• loss of heat from the body
• loss of strength or energy
• lower back or side pain
• mental depression
• mimicry of speech or movements
• muscle pain or weakness
• mutism
• nausea or vomiting
• negativism
• night blindness
• noisy breathing
• overbright appearance of lights
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• paleness or cold feeling in the fingertips and toes
• paranoia
• peculiar postures or movements, mannerisms or grimacing
• persistent non-healing sore
• pink growth
• pinpoint red or purple spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• quick to react or overreact emotionally
• rapidly changing moods
• rectal bleeding
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• reddening of the skin, especially around the ears
• reddish patch or irritated area
• runny nose
• scaly skin
• seeing, hearing, or feeling things that are not there
• severe sleepiness
• severe sunburn
• shiny bump
• short-term memory loss
• skin irritation or rash, including rash that looks like psoriasis
• sleeplessness
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain or tenderness
• sugar in the urine
• sweating
• swelling of the eyes, face, or inside of the nose
• swelling of the fingers, feet, or lower legs
• tender, swollen, or painful glands in the neck
• tenderness of salivary glands
• tenderness, burning, or peeling of the skin
• thickening of bronchial secretions
• tingling or pain in the fingers or toes when exposed to cold
• trouble breathing
• trouble with sleeping
• trouble with swallowing
• tunnel vision
• unable to sleep
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight loss
• unusually warm skin
• voice changes
• vomiting of blood
• weight gain
• white, yellow or waxy scar-like area
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Change in consciousness
• decreased urination
• fast, slow, or shallow breathing
• gas
• heartburn
• increase in heart rate
• increased sweating
• indigestion
• loss of consciousness
• low blood pressure
• muscle cramps
• pale or blue lips, fingernails, or skin
• rapid breathing
• seizures
• sunken eyes
• unusual drowsiness, dullness, or feeling of sluggishness
• unusual paleness
• weakness and heaviness of the legs
• wrinkled skin

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:

Incidence not known

• Decreased interest in sexual intercourse
• dry eyes
• feeling of constant movement of self or surroundings
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• muscle spasm
• pain of the penis on erection
• pain or discomfort in the chest, upper stomach, or throat
• restlessness
• sensation of spinning
• stomach cramps
• thinning of the hair
• vivid dreams

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.

In the U.S.

• Inderide

Available Dosage Forms:

• Tablet

Therapeutic Class: Beta-Adrenergic Blocker, Nonselective/Thiazide Combination

Pharmacologic Class: Propranolol

Chemical Class: Thiazide

This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Swallow the tablet 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 (tablets):For high blood pressure: Adults—One tablet two times a day. Your doctor may adjust your dose if needed. 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.