Hydrochlorothiazide and lisinopril

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

You should not use this medicine if you have hereditary angioedema, if you are unable to urinate, if you are allergic to sulfa drugs, or if you have ever had a severe allergic reaction to any ACE inhibitor.

If you have diabetes, do not use hydrochlorothiazide and lisinopril together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo).

Get emergency medical help if you have signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• eye pain, vision problems;

• little or no urination;

• weakness, drowsiness, or feeling restless;

• fever, chills, sore throat, mouth sores, trouble swallowing;

• jaundice (yellowing of the skin or eyes);

• high potassium--nausea, slow or unusual heart rate, weakness, loss of movement;

• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling; or

• low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Common side effects may include:

• cough;

• headache;

• dizziness; or

• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Hypertension:

Initial dose: Hydrochlorothiazide 12.5 mg-Lisinopril 10 to 20 mg orally once a day, depending on the current monotherapy dose

Maximum dose: Hydrochlorothiazide 50 mg-Lisinopril 80 mg per day

Comments:
-May increase dose every 2 to 3 weeks.
-If blood pressure is controlled with monotherapy hydrochlorothiazide 25 mg per day, but significant potassium loss occurs, then similar or greater blood pressure control without electrolyte disturbance may be achieved with hydrochlorothiazide 12.5 mg-lisinopril 10 mg orally once a day.

Applies to hydrochlorothiazide / lisinopril: oral tablet

Along with its needed effects, hydrochlorothiazide / lisinopril 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 while taking hydrochlorothiazide / lisinopril:

• Blurred vision
• body aches or pain
• chills
• confusion
• cough
• diarrhea
• difficulty breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• nausea
• runny nose
• sneezing
• sore throat
• sweating
• unusual tiredness or weakness
• vomiting

Some side effects of hydrochlorothiazide / lisinopril 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:

• Acid or sour stomach
• belching
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• decreased interest in sexual intercourse
• heartburn
• inability to have or keep an erection
• indigestion
• lack or loss of strength
• loss in sexual ability, desire, drive, or performance
• muscle cramps
• rash
• stomach discomfort, upset, or pain

Applies to hydrochlorothiazide / lisinopril: oral tablet

General

The most common adverse reactions were dizziness, headache, cough, fatigue, and orthostatic effects.[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, paresthesia
Uncommon (0.1% to 1%): Syncope
Frequency not reported: Vertigo, somnolence, tinnitus

Hydrochlorothiazide:
Frequency not reported: Paresthesia, lightheadedness, vertigo

Lisinopril:
Common (1% to 10%): Dizziness, headache, syncope
Uncommon (0.1% to 1%): Paresthesia, vertigo, taste disturbance
Rare (less than 0.1%): Olfactory disturbance
Frequency not reported: Transient ischemic attacks, ataxia, memory impairment, tremor, stroke, peripheral neuropathy, hypersomnia[Ref]

Respiratory

Common (1% to 10%): Cough, upper respiratory tract infection
Frequency not reported: Common cold, nasal congestion, bronchitis, pharyngeal pain, dyspnea, pulmonary congestion, chronic sinusitis, allergic rhinitis, pharyngeal discomfort

Hydrochlorothiazide:
Frequency not reported: Respiratory distress, pneumonitis, pulmonary edema

Lisinopril:
Common (1% to 10%): Cough
Uncommon (0.1% to 1%): Rhinitis
Very rare (less than 0.01%): Bronchospasm, sinusitis, allergic alveolitis/eosinophilic pneumonitis
Frequency not reported: Pulmonary embolism, pulmonary infarction, paroxysmal nocturnal dyspnea, malignant lung neoplasms, hemoptysis, pulmonary edema, pulmonary infiltrates, asthma, pleural effusion, pneumonia, wheezing, orthopnea, painful respiration, epistaxis, laryngitis, pharyngitis, rhinorrhea[Ref]

Other

Common (1% to 10%): Fatigue, asthenia
Frequency not reported: Chest pain, chest discomfort, fever, trauma, otalgia

Hydrochlorothiazide:
Frequency not reported: Fever, weakness, cramping

Lisinopril:
Uncommon (0.1% to 1%): Asthenia, fatigue
Frequency not reported: Malaise, edema, facial edema, pain, chills, peripheral edema, chest sound abnormal, breast pain[Ref]

Cardiovascular

Common (1% to 10%): Orthostatic effects, hypotension
Frequency not reported: Palpitation, flushing

Hydrochlorothiazide:
Frequency not reported: Postural hypotension, necrotizing angiitis, vasculitis

Lisinopril:
Common (1% to 10%): Orthostatic effects
Uncommon (0.1% to 1%): Myocardial infarction or cerebrovascular accident, palpitation, tachycardia, Raynaud's syndrome
Frequency not reported: Flushing, cardiac arrest, worsening heart failure, arrhythmias, angina pectoris, decreased blood pressure, vasculitis[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, vomiting, dyspepsia
Frequency not reported: Abdominal pain, gastrointestinal cramps, dry mouth, constipation, heartburn, intestinal angioedema

Hydrochlorothiazide:
Frequency not reported: Sialadenitis, gastric irritation, diarrhea, constipation, pancreatitis

Lisinopril:
Common (1% to 10%): Diarrhea, vomiting
Uncommon (0.1% to 1%): Nausea, abdominal pain, indigestion
Rare (0.01% to 0.1%): Dry mouth
Very rare (less than 0.01%): Pancreatitis, intestinal angioedema
Frequency not reported: Gastritis, flatulence, salivation increased[Ref]

Musculoskeletal

Common (1% to 10%): Muscle cramps
Frequency not reported: Back pain, shoulder pain, knee pain, back strain, myalgia, foot pain

Hydrochlorothiazide:
Frequency not reported: Systemic lupus erythematosus, muscle spasm, muscle weakness

Lisinopril:
Frequency not reported: Pelvic pain, flank pain, arthritis, arthralgia, neck pain, hip pain, joint pain, leg pain, arm pain, lumbago[Ref]

Genitourinary

Common (1% to 10%): Impotence
Frequency not reported: Urinary tract infection

Hydrochlorothiazide:
Frequency not reported: Glycosuria

Lisinopril:
Uncommon (0.1% to 1%): Impotence
Frequency not reported: Dysuria[Ref]

Dermatologic

Frequency not reported: Pruritus, skin inflammation, diaphoresis, cutaneous pseudolymphoma, angioedema

Hydrochlorothiazide:
Frequency not reported: Cutaneous vasculitis, photosensitivity reactions, rash, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, urticaria, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, alopecia, purpura

Lisinopril:
Uncommon (0.1% to 1%): Rash, pruritus
Rare (0.01% to 0.1%): Angioedema, urticaria, alopecia, psoriasis
Very rare (less than 0.01%): Diaphoresis, pemphigus, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, cutaneous pseudolymphoma
Frequency not reported: Photosensitivity, skin lesions, skin infections[Ref]

Ocular

Frequency not reported: Xanthopsia, transient blurred vision, acute myopia, acute angle-closure glaucoma

Hydrochlorothiazide:
Frequency not reported: Xanthopsia

Lisinopril:
Frequency not reported: Visual loss, diplopia, photophobia[Ref]

Hematologic

Frequency not reported: Hemoglobin decreased, hematocrit decreased, anemia

Hydrochlorothiazide:
Frequency not reported: Leukopenia, neutropenia/agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, bone marrow depression

Lisinopril:
Rare (0.01% to 0.1%): Hemoglobin decreased, hematocrit decreased
Very rare (less than 0.01%): Bone marrow depression, anemia, thrombocytopenia, leukopenia, neutropenia, agranulocytosis, hemolytic anemia, lymphadenopathy[Ref]

Renal

Frequency not reported: BUN increased, serum creatinine increased

Hydrochlorothiazide:
Frequency not reported: Renal dysfunction, interstitial nephritis, renal failure

Lisinopril:
Common (1% to 10%): Renal dysfunction
Uncommon (0.1% to 1%): Blood urea increased, serum creatinine increased
Rare (0.01% to 0.1%): Uremia, acute renal failure
Very rare (less than 0.01%): Oliguria/anuria
Frequency not reported: Progressive azotemia, pyelonephritis[Ref]

Psychiatric

Frequency not reported: Libido decreased, depression

Hydrochlorothiazide:
Frequency not reported: Restlessness, depression, sleep disturbance

Lisinopril:
Uncommon (0.1% to 1%): Sleep disturbance, mood alteration, depressive symptoms
Rare (less than 0.1%): Mental confusion
Frequency not reported: Hallucination, insomnia, nervousness, irritability[Ref]

Hepatic

Frequency not reported: Liver enzymes elevated, bilirubin elevated

Hydrochlorothiazide:
Frequency not reported: Intrahepatic cholestatic jaundice

Lisinopril:
Uncommon (0.1% to 1%): Liver enzymes elevated, bilirubin elevated
Very rare (less than 0.01%): Hepatitis, jaundice, hepatic failure[Ref]

Immunologic

Frequency not reported: Viral infection, influenza

Hydrochlorothiazide:
Frequency not reported: Anaphylactic reactions

Lisinopril:
Very rare (less than 0.01%): Autoimmune disease
Frequency not reported: Anaphylactoid reactions, herpes zoster[Ref]

Metabolic

Hydrochlorothiazide:
Frequency not reported: Anorexia, hyperglycemia, hyperuricemia, hyponatremia, hypokalemia, hypochloremic alkalosis, hypomagnesemia, cholesterol increased, triglycerides increased, gout, appetite lost

Lisinopril:
Uncommon (0.1% to 1%): Hyperkalemia
Rare (0.01% to 0.1%): Hyponatremia
Very rare (less than 0.01%): Hypoglycemia
Frequency not reported: Anorexia, gout, weight loss, dehydration, fluid overload, weight gain[Ref]

Endocrine

Lisinopril:
Rare (less than 0.1%): Syndrome of inappropriate antidiuretic hormone secretion, gynecomastia
Frequency not reported: Diabetes mellitus[Ref]

Some side effects of hydrochlorothiazide / lisinopril may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Mild to moderate renal dysfunction (CrCl greater than 30 mL/min): No adjustment recommended.
Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended; loop diuretics preferred over thiazides

US BOXED WARNING:
-FETAL TOXICITY: If pregnancy is detected, discontinue this drug as soon as possible. Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Animal studies have revealed evidence of decreased fetal weight and delayed fetal ossification in the presence of maternal weight gain. In humans, use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity and death. There are no controlled data in human pregnancy. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

UK: Use is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters. US: This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus. US FDA pregnancy category: D Comments: Adequate methods of contraception should be encouraged.