Kapspargo Sprinkle

What Is Kapspargo Sprinkle?

Kapspargo Sprinkle (metoprolol succinate) is a beta-selective adrenoceptor blocking agent indicated for the treatment of high blood pressure (hypertension), to lower blood pressure; angina pectoris; and heart failure.

What Are Side Effects of Kapspargo Sprinkle?

Common side effects of Kapspargo Sprinkle include:

• tiredness,
• dizziness,
• depression,
• shortness of breath,
• bradycardia,
• hypotension,
• diarrhea,
• pruritus,
• rash

Dosage for Kapspargo Sprinkle

The usual initial dosage of Kapspargo Sprinkle to treat hyptertension in adults is 25 to 100 mg once daily. The recommended starting dose of Kapspargo Sprinkle to treat pediatric hypertension in children 6 years of age and older is 1 mg/kg, once daily and adjust to response. The usual initial dosage of Kapspargo Sprinkle to treat angina pectoris is 100 mg once daily. The recommended starting dose Kapspargo Sprinkle to treat heart failure is 25 mg once daily doubled every two weeks to the highest dose tolerated or up to 200 mg.

What Drugs, Substances, or Supplements Interact with Kapspargo Sprinkle?

Kapspargo Sprinkle may interact with reserpine, monoamine oxidase inhibitors (MAOIs), epinephrine, quinidine, fluoxetine, paroxetine, propafenone, digitalis glycosides, clonidine, diltiazem, verapamil, and alcohol.

Kapspargo Sprinkle During Pregnancy and Breastfeeding

Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Kapspargo Sprinkle; untreated hypertension and heart failure during pregnancy can lead to adverse outcomes for the mother and the fetus. Kapspargo Sprinkle passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Kapspargo Sprinkle (metoprolol succinate) Capsules Extended-Release, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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

Call your doctor at once if you have:

• very slow heartbeats;
• a light-headed feeling, like you might pass out;
• shortness of breath (even with mild exertion), swelling, rapid weight gain; or
• cold feeling in your hands and feet.

Common side effects may include:

• dizziness, tired feeling;
• depression, confusion, memory problems;
• nightmares, trouble sleeping;
• diarrhea; or
• mild itching or rash.

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.

Read the entire detailed patient monograph for Kapspargo Sprinkle (Metoprolol Succinate Capsules )

 

Kapspargo Sprinkle Professional Information

SIDE EFFECTS

The following adverse reactions are described elsewhere in labeling:

• Worsening angina or myocardial infarction. [see WARNINGS AND PRECAUTIONS]
• Worsening heart failure. [see WARNINGS AND PRECAUTIONS]
• Worsening AV block. [see CONTRAINDICATIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Hypertension And Angina

Most adverse reactions have been mild and transient. The most common (>2%) adverse reactions are tiredness, dizziness, depression, diarrhea, shortness of breath, bradycardia, and rash.

Heart Failure

In the MERIT-HF study comparing metoprolol succinate in daily doses up to 200 mg (mean dose 159 mg once-daily; n=1990) to placebo (n=2001), 10.3% of metoprolol succinate patients discontinued for adverse events vs. 12.2% of placebo patients.

The table below lists adverse reactions in the MERIT-HF study that occurred at an incidence of ≥ 1% in the metoprolol succinate group and greater than placebo by more than 0.5%, regardless of the assessment of causality.

Adverse Reactions Occurring in the MERIT-HF Study at an Incidence ≥ 1% in the Metoprolol Succinate Group and Greater Than Placebo by More Than 0.5%

	Metoprolol Succinate n = 1990 % of patients	Placebo n = 2001 % of patients
Dizziness/vertigo	1.8	1
Bradycardia	1.5	0.4

Post-Operative Adverse Events

In a randomized, double-blind, placebo-controlled trial of 8351 patients with or at risk for atherosclerotic disease undergoing non-vascular surgery and who were not taking beta–blocker therapy, metoprolol succinate 100 mg was started 2 to 4 hours prior to surgery then continued for 30 days at 200 mg per day. Metoprolol succinate use was associated with a higher incidence of bradycardia (6.6% vs. 2.4%; HR, 2.74; 95% CI 2.19, 3.43), hypotension (15% vs. 9.7%; HR 1.55; 95% CI 1.37, 1.74), stroke (1% vs. 0.5%; HR 2.17; 95% CI 1.26, 3.74) and death (3.1% vs. 2.3%; HR 1.33; 95% CI 1.03, 1.74) compared to placebo.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of extended-release metoprolol or immediate-release metoprolol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: Cold extremities, arterial insufficiency (usually of the Raynaud type), palpitations, peripheral edema, syncope, chest pain and hypotension.

Respiratory: Wheezing (bronchospasm), dyspnea.

Central Nervous System: Confusion, short-term memory loss, headache, somnolence, nightmares, insomnia, anxiety/nervousness, hallucinations, paresthesia.

Gastrointestinal: Nausea, dry mouth, constipation, flatulence, heartburn, hepatitis, vomiting.

Hypersensitive Reactions: Pruritus.

Miscellaneous: Musculoskeletal pain, arthralgia, blurred vision, decreased libido, male impotence, tinnitus, reversible alopecia, agranulocytosis, dry eyes, worsening of psoriasis, Peyronie's disease, sweating, photosensitivity, taste disturbance.

Potential Adverse Reactions

In addition, there are adverse reactions not listed above that have been reported with other betaadrenergic blocking agents and should be considered potential adverse reactions to metoprolol succinate.

Central Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, clouded sensorium, and decreased performance on neuropsychometrics.

Hematologic: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.

Hypersensitive Reactions: Laryngospasm, respiratory distress.

DRUG INTERACTIONS

Catecholamine Depleting Drugs

Catecholamine depleting drugs (e.g., reserpine, monoamine oxidase (MAO) inhibitors) may have an additive effect when given with beta-blocking agents. Observe patients treated with metoprolol succinate plus a catecholamine depletor for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.

Epinephrine

While taking beta-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenge and may be unresponsive to the usual doses of epinephrine used to treat an allergic reaction.

CYP2D6 Inhibitors

Drugs that are strong inhibitors of CYP2D6, such as quinidine, fluoxetine, paroxetine, and propafenone, were shown to double metoprolol concentrations. While there is no information about moderate or weak inhibitors, these too are likely to increase metoprolol concentration. Increases in plasma concentration decrease the cardioselectivity of metoprolol [see CLINICAL PHARMACOLOGY]. Monitor patients closely, when the combination cannot be avoided.

Digitalis, Clonidine, And Calcium Channel Blockers

Digitalis glycosides, clonidine, diltiazem and verapamil slow atrioventricular conduction and decrease heart rate. Concomitant use with beta blockers can increase the risk of bradycardia.

If clonidine and a beta blocker, such as metoprolol are coadministered, withdraw the beta-blocker several days before the gradual withdrawal of clonidine because beta-blockers may exacerbate the rebound hypertension that can follow the withdrawal of clonidine. If replacing clonidine by beta-blocker therapy, delay the introduction of beta-blockers for several days after clonidine administration has stopped.

Alcohol

Metoprolol succinate is released faster from KAPSPARGO SPRINKLE in the presence of alcohol. This may increase the risk for adverse events associated with KAPSPARGO SPRINKLE. Avoid alcohol consumption when taking KAPSPARGO SPRINKLE [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Kapspargo Sprinkle (Metoprolol Succinate Capsules )