Prilosec OTC

Generic Name: omeprazole (Oral route)

oh-MEP-ra-zole

Commonly used brand name(s)

In the U.S.

• Prilosec


• Prilosec OTC

Available Dosage Forms:

• Tablet, Delayed Release


• Capsule, Delayed Release


• Packet

Pharmacologic Class: Proton Pump Inhibitor

Uses For Prilosec OTC

Omeprazole is used to treat certain conditions where there is too much acid in the stomach. It is used to treat gastric and duodenal ulcers, erosive esophagitis, and gastroesophageal reflux disease (GERD). GERD is a condition where the acid in the stomach washes back up into the esophagus. Sometimes omeprazole is used in combination with antibiotics (e.g., amoxicillin, clarithromycin) to treat ulcers associated with infection caused by the H. pylori bacteria (germ).

Omeprazole is also used to treat Zollinger-Ellison syndrome, a condition where the stomach produces too much acid.

Omeprazole is also used to treat dyspepsia, a condition that causes sour stomach, belching, heart burn, or indigestion.

In addition, omeprazole is used to prevent upper gastrointestinal tract bleeding in seriously ill patients.

Omeprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using Prilosec OTC

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of omeprazole in children 1 to 16 years of age. Safety and efficacy have not been established in children younger than 1 year of age. .

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of omeprazole in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

• Rilpivirine

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.

• Atazanavir


• Bendamustine


• Citalopram


• Clopidogrel


• Clorazepate


• Dasatinib


• Delavirdine


• Erlotinib


• Indinavir


• Methotrexate


• Mycophenolate Mofetil


• Nelfinavir


• Nilotinib

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.

• Armodafinil


• Carbamazepine


• Cilostazol


• Cranberry


• Digoxin


• Disulfiram


• Fluconazole


• Ginkgo Biloba


• Iron


• Raltegravir


• Saquinavir


• St John's Wort


• Tipranavir


• Triazolam


• Voriconazole


• Warfarin

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.

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:

• Hypomagnesemia (low magnesium in the blood), history of or


• Osteoporosis (bone problem) or


• Seizures, history of—Use with caution. May make these conditions worse.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of omeprazole

This section provides information on the proper use of a number of products that contain omeprazole. It may not be specific to Prilosec OTC. Please read with care.

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. If you are using this medicine without a prescription, follow the instructions on the medicine label.

Take omeprazole capsules or delayed-release capsules before a meal, preferably in the morning. Omeprazole tablets may be taken with food or on an empty stomach. Take omeprazole powder for oral suspension on an empty stomach at least 1 hour before a meal. For patients receiving continuous feeding through a tube, feeding should be temporarily stopped about 3 hours before and 1 hour after administration of omeprazole powder for oral suspension.

It may take several days before this medicine begins to relieve stomach pain. To help relieve this pain, antacids may be taken with omeprazole, unless your doctor has told you not to use them.

If you are taking this medicine to treat an ulcer that is associated with an H. pylori infection, take it together with the antibiotics (e.g., amoxicillin, clarithromycin) at the same time of day.

Swallow the capsule and tablet forms of omeprazole whole. Do not open the capsule. Do not crush, break, or chew the capsule or the tablet.

If you cannot swallow the omeprazole delayed-release capsules, you may open it and sprinkle the pellets contained in the capsule on one tablespoon of applesauce. This mixture must be swallowed immediately with a glass of cool water. The applesauce should not be hot and should be soft enough to be swallowed without chewing. Do not chew or crush the pellets.

To use the powder for oral suspension:

• Empty packet of powder into a small cup containing 2 tablespoons of water.


• Do not use other liquids or foods.


• Stir well and drink immediately.


• Refill cup with water and drink.

To use the delayed-release oral suspension:

• Empty the contents of a 2.5 milligrams (mg) packet of powder into a container containing 5 mL of water.


• Empty the contents of a 10 mg packet of powder into a container containing 15 mL of water.


• Do not use other liquids or foods.


• Stir and leave it for 2 to 3 minutes to thicken.


• Stir well and drink within 30 minutes.


• If any medicine remains after drinking, add more water, stir, and drink immediately.

If you are using the delayed-release oral suspension with a nasogastric or gastric tube:

• Add 5 mL to a catheter tipped syringe and then add the contents of a 2.5 mg packet (or 15 mL of water for the 10 mg packet).


• Shake the syringe right away and leave it for 2 to 3 minutes to thicken.


• Shake the syringe and give the medicine through the nasogastric or gastric tube into the stomach with 30 minutes.


• Refill the syringe with an equal amount of water.


• Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

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 forms (capsules, delayed-release capsules or suspension, or tablets):
  
  • To treat duodenal ulcers:
    
    • Adults—20 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat duodenal ulcers with H. pylori:
    
    • Adults—20 or 40 milligrams (mg) one or two times a day before a meal. The dose is usually taken together with clarithromycin or clarithromycin plus amoxicillin. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat erosive esophagitis:
    
    • Adults—20 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat gastric ulcers:
    
    • Adults—40 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat gastroesophageal reflux disease (GERD):
    
    • Adults—20 milligrams (mg) once a day before a meal. Your doctor may tell you to take 40 mg a day for certain conditions. Also, your doctor may want you to take omeprazole for more than 8 weeks for certain conditions.
    
    
    • Children 1 year of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 to 20 mg once a day before a meal.
    
    
    • Children younger than 1 year of age—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat Zollinger-Ellison syndrome:
    
    • Adults—60 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

• For oral dosage forms (powder for suspension):
  
  • To prevent upper gastrointestinal tract bleeding in seriously ill patients:
    
    • Adults—The first day: 40 milligrams (mg) for the first dose; then after 6 to 8 hours, a second 40 mg dose. After the first day: 40 mg once a day for up to 14 days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat duodenal ulcer:
    
    • Adults—20 milligrams (mg) once a day for 4 to 8 weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat gastric ulcers:
    
    • Adults—40 milligrams (mg) once a day for 4 to 8 weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat gastroesophageal reflux disease (GERD) for erosive esophagitis:
    
    • Adults—20 milligrams (mg) once a day for 4 to 8 weeks.
    
    
    • 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.

Precautions While Using Prilosec OTC

It is important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects. If your or your child's condition does not improve, or if it becomes worse, check with your doctor.

Tell your doctor if you or your child have Asian relatives, such as Filipino, Chinese, Japanese, Korean, or Taiwanese. You may need a lower dose of this medicine to treat erosive esophagitis.

This medicine is sometimes given together with other medicines to treat ulcers. Be sure you understand about the risks and proper use of any other medicine your doctor gives you or your child together with omeprazole.

Omeprazole may cause a serious type of allergic reaction when used in patients with conditions treated with antibiotics. Call your doctor right away if you or your child have itching; trouble breathing or swallowing; or any swelling of your hands, face, or mouth while you or your child are using this medicine.

Serious stomach conditions may occur while taking this medicine with antibiotics. Stop using this medicine and check with your doctor immediately if you or your child are having more than one of these symptoms: abdominal or stomach cramps, bloated feeling, watery and severe diarrhea which may also be bloody sometimes, fever, nausea or vomiting, unusual tiredness or weakness.

This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more.

This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Stop using this medicine and check with your doctor right away if you have convulsions (seizures); fast, racing, or uneven heartbeat; muscle spasms (tetany); tremors; or unusual tiredness or weakness.

Do not stop taking this medicine without first checking with your doctor, or unless told to do so by your doctor.

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.

Prilosec OTC 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:

Rare

• Back, leg, or stomach pain


• bleeding or crusting sores on the lips


• blisters


• bloody or cloudy urine


• chills


• continuing ulcers or sores in the mouth


• difficult, burning, or painful urination


• fever


• frequent urge to urinate


• general feeling of discomfort or illness


• joint pain


• loss of appetite


• muscle aches or cramps


• pain


• red or irritated eyes


• redness, tenderness, itching, burning, or peeling of the skin


• skin rash or itching


• sore throat


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


• unusual bleeding or bruising


• unusual tiredness or weakness

Incidence not known

• Drowsiness


• fast, racing, or uneven heartbeat


• mood or mental changes


• muscle spasms (tetany) or twitching seizures


• nausea or vomiting


• trembling

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

Symptoms of overdose

• Blurred vision


• confusion


• dryness of the mouth


• flushing


• headache


• increased sweating

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:

Less common

• Body aches or pain


• chest pain


• constipation


• cough


• diarrhea or loose stools


• difficulty with breathing


• dizziness


• ear congestion


• gas


• heartburn


• loss of voice


• muscle pain


• nasal congestion


• runny nose


• sneezing


• unusual drowsiness

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.

See also: Prilosec OTC side effects (in more detail)

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More Prilosec OTC resources

• Prilosec OTC Side Effects (in more detail)
• Prilosec OTC Use in Pregnancy & Breastfeeding
• Prilosec OTC Drug Interactions
• Prilosec OTC Support Group
• 7 Reviews for Prilosec OTC - Add your own review/rating

• Prilosec OTC Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Omeprazole Prescribing Information (FDA)


• Omeprazole Professional Patient Advice (Wolters Kluwer)


• Omeprazole Monograph (AHFS DI)


• Omeprazole Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Prilosec Prescribing Information (FDA)


• Prilosec Consumer Overview

Compare Prilosec OTC with other medications

• GERD
• Indigestion

Prezista

Generic Name: Darunavir
Class: HIV Protease Inhibitors
VA Class: AM800
Chemical Name: [(1S,2R) - 3 - [[(4 - Aminophenyl)sulfonyl](2 - methylpropyl)amino] - 2 - hydroxy - 1 - (phenylmethyl)propyl] - carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester
Molecular Formula: C₂₇H₃₇N₃O₇SC₂₇H₃₇N₃O₇S•C₂H₅OH
CAS Number: 206361-99-1

Introduction

Antiretroviral; HIV protease inhibitor (PI).^{1 2 3}

Uses for Prezista

Treatment of HIV Infection

Treatment of HIV infection.¹ Used in conjunction with low-dose ritonavir (ritonavir-boosted darunavir) and other antiretroviral agents.¹

Ritonavir-boosted darunavir is a preferred PI for initial treatment regimens in adults.⁴

Treatment-experienced patients: Use of ritonavir-boosted darunavir should be guided by genotypic and phenotypic viral resistance testing and the individual’s prior antiretroviral treatment.¹

Prezista Dosage and Administration

Administration

Oral Administration

Administer orally in conjunction with low-dose ritonavir (ritonavir-boosted darunavir).^{1 4} Do not use without low-dose ritonavir.¹

Take darunavir and low-dose ritonavir at same time and with food.¹

Administered once daily in treatment-naive adults.¹

Administered twice daily in pediatric patients and treatment-experienced adults.¹

Ensure that pediatric patients can swallow tablets; those unable to swallow tablets are not candidates for ritonavir-boosted darunavir therapy.¹

Dosage

Available as darunavir ethanolate; dosage expressed in terms of darunavir.¹

Pediatric Patients

Treatment of HIV Infection

To avoid medication errors, use extra care in calculating the dose, transcribing the medication order, dispensing the prescription, and providing dosing instructions.¹

Dosage of ritonavir-boosted darunavir in children 6–<18 years of age weighing at least 20 kg is based on weight.¹

Table 1: Dosage for Ritonavir-boosted Darunavir for Pediatric Patients 6–<18 Years of Age1

Body weight	Darunavir dosage	Ritonavir dosage
20 to < 30 kg	375 mg twice daily	50 mg twice daily
30 to < 40 kg	450 mg twice daily	60 mg twice daily
≥ 40 kg	600 mg twice daily	100 mg twice daily

Adults

Treatment of HIV Infection

Treatment-naive Adults

Oral

800 mg once daily boosted with low-dose ritonavir (100 mg once daily).¹

Treatment-experienced Adults

Oral

600 mg twice daily boosted with low-dose ritonavir (100 mg twice daily).¹

Prescribing Limits

Pediatric Patients

Treatment of HIV Infection

Oral

Do not exceed dosage for treatment-experienced adults.¹

Special Populations

Hepatic Impairment

Dosage adjustment not needed in patients with mild to moderate hepatic impairment (Child-Pugh class A or B).^{1 4} Do not use in those with severe hepatic impairment (Child-Pugh class C).^{1 4}

Renal Impairment

Some experts state that dosage adjustments are not necessary.⁴

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹

Cautions for Prezista

Contraindications

• 
  

  Concomitant use with drugs highly dependent on CYP3A for metabolism and for which elevated plasma concentrations are associated with serious and/or life-threatening events and other drugs that may lead to loss of virologic response (e.g., cisapride, ergot alkaloids, lovastatin, oral midazolam, pimozide, rifampin, simvastatin, St. John’s wort [Hypericum perforatum], triazolam).¹ (See Specific Drugs under Interactions.)

  
  

Warnings/Precautions

Warnings

Hepatic Effects

Acute hepatitis reported in clinical studies.¹ Liver injury (in some cases fatal) reported during postmarketing surveillance; liver injury generally occurred in patients with advanced HIV infection who were receiving multiple concomitant drugs, who were coinfected with hepatitis B virus (HBV) or hepatitis C virus (HCV), and/or were developing immune reconstitution syndrome.¹

Conduct appropriate laboratory tests before starting darunavir; monitor periodically thereafter.¹ Consider increased AST/ALT monitoring in patients with hepatitis, cirrhosis, or elevated transaminase values prior to therapy, especially during the first several months of therapy.¹

Consider interrupting or discontinuing darunavir in patients who develop manifestations suggestive of hepatic impairment (e.g., fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly, clinically important increases in hepatic enzyme concentrations).¹

Interactions

Darunavir is administered concomitantly with low-dose ritonavir (ritonavir-boosted darunavir).¹ Failure to administer with recommended low-dose ritonavir will result in subtherapeutic darunavir concentrations and inadequate antiviral response.¹ The usual cautions, precautions, and contraindications associated with ritonavir should be considered.¹

Concomitant use with certain drugs is not recommended or requires particular caution (e.g., sildenafil, tadalafil, vardenafil).^{1 4} (See Specific Drugs under Interactions.)

Hyperglycemic and Diabetogenic Effects

Hyperglycemia (potentially persistent), new-onset diabetes mellitus, or exacerbation of preexisting diabetes mellitus reported with use of PIs; diabetic ketoacidosis has occurred.¹

Initiate or adjust antidiabetic therapy (e.g., insulin, oral hypoglycemic agents) as needed.¹

Sensitivity Reactions

Sulfonamide Sensitivity

Darunavir contains a sulfonamide moiety; use with caution in patients with known sulfonamide allergy.¹

Dermatologic Reactions

Severe skin reactions, including Stevens-Johnson syndrome reported;¹ fever and increased serum transaminase concentrations also may occur.¹

Discontinue darunavir if severe rash occurs.¹

General Precautions

Hemophilia A and B

Spontaneous bleeding reported with PIs;¹ causal relationship not established.¹

Use with caution in patients with history of hemophilia A or B.¹ Increased hemostatic therapy (e.g., antihemophilic factor) may be needed.¹

Adipogenic Effects

Possible redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and general cushingoid appearance.¹

Immune Reconstitution Syndrome

During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jiroveci [formerly P. carinii]; this may necessitate further evaluation and treatment.¹

HIV Resistance

Possibility of cross-resistance to other PIs not evaluated.¹ Effect of ritonavir-boosted darunavir therapy on subsequent therapy with other PIs unknown.¹

Specific Populations

Pregnancy

Category C.¹

Antiretroviral Pregnancy Registry at 800-258-4263.¹

Some experts state safety and pharmacokinetic data insufficient to recommend ritonavir-boosted darunavir in pregnant women.⁷

Lactation

Distributed into milk in rats;¹ not known whether distributed into human milk.¹

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.¹

Pediatric Use

Adverse effects in children 6–<18 years of age similar to those reported in adults.¹

Safety, efficacy, and pharmacokinetic profile not established in children 3 to <6 years of age.¹

Should not be used in children <3 years of age because of toxicity and mortality in juvenile rats.¹

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.¹

Use with caution and monitor because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹

Hepatic Impairment

Risk for liver function abnormalities, including severe adverse hepatic effects, in patients with preexisting hepatic impairment, including those with HBV or HCV infection.¹

Pharmacokinetics not altered in individuals with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.¹

Use not recommended in patients with severe hepatic impairment.¹

Renal Impairment

Pharmacokinetics not altered in patients with Cl_cr≥30 mL/minute.¹ Not studied in patients with severe renal impairment or end-stage renal disease.¹

Common Adverse Effects

Diarrhea,^{1 9} nausea,^{1 9} headache,^{1 9} abdominal pain.¹

Interactions for Prezista

Darunavir metabolized principally by CYP3A.¹

Darunavir and ritonavir inhibit CYP3A4 and CYP2D6.¹

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions likely with drugs that are inhibitors or inducers of CYP3A4 with possible alteration in metabolism of darunavir or ritonavir.¹

Potential pharmacokinetic interaction with drugs metabolized by CYP3A or CYP2D6 with possible altered metabolism of drug metabolized by CYP3A or CYP2D6.¹

Specific Drugs

Drug	Interaction	Comments
Abacavir	Pharmacokinetic interaction not expected1 No in vitro evidence of antagonistic antiretroviral effects 1
Antiarrhythmic agents (amiodarone, flecainide, systemic lidocaine, propafenone, quinidine)	Possible increased plasma concentrations of antiarrhythmic agents1	Monitor antiarrhythmic concentrations1
Anticoagulants	Decreased warfarin concentrations1	Monitor INR 1
Anticonvulsants (carbamazepine, phenobarbital, phenytoin)	Carbamazepine: Increased carbamazepine concentrations1 Phenobarbital, phenytoin: Decreased concentrations of the anticonvulsant1	Carbamazepine: Dosage adjustment not needed; monitor carbamazepine concentrations and adjust dose to achieve appropriate clinical effect1 Phenobarbital, phenytoin: Monitor anticonvulsant concentrations1
Antifungals (itraconazole, ketoconazole, voriconazole)	Itraconazole: Increased darunavir and itraconazole concentrations1 Ketoconazole: Increased darunavir and ketoconazole concentrations1 Voriconazole: Decreased voriconazole concentrations1	Itraconazole: Dosage >200 mg daily not recommended1 4 Ketoconazole: Dosage >200 mg daily not recommended 1 4 Voriconazole: Concomitant use not recommended unless benefits outweigh risks1 4
Antimycobacterials, rifamycins (rifabutin, rifampin, rifapentine)	Rifabutin: Increased rifabutin and darunavir concentrations1 Rifampin: Decreased darunavir concentrations; possible decreased antiretroviral activity1	Rifabutin: Reduce rifabutin dosage to 150 mg once every other day (further reduction may be needed); monitor for adverse effects1 4 Rifampin: Concomitant use contraindicated 1 4 Rifapentine: Concomitant use not recommended4
Atazanavir	Plasma concentration of atazanavir with ritonavir-boosted darunavir similar to ritonavir-boosted atazanavir; no change in darunavir concentrations1 No in vitro evidence of antagonistic antiretroviral effects1	Manufacturer and some experts state atazanavir 300 mg once daily can be used with ritonavir-boosted darunavir1 4
β-Adrenergic blocking agents (metoprolol, timolol)	Metoprolol, timolol: Possible increased concentrations of the β-adrenergic blocking agent1	Metoprolol, timolol: Caution; dose reduction of the β-adrenergic blocking agent may be needed1
Benzodiazepines (e.g., midazolam, triazolam)	Possible increased concentrations of midazolam or triazolam; potential for serious and/or life-threatening effects (e.g., prolonged or increased sedation or respiratory depression)1	Concomitant use with oral midazolam or triazolam contraindicated;1 some experts state a single parenteral dose of midazolam can be used with caution in a monitored situation for procedural sedation4
Calcium-channel blocking agents (e.g., felodipine, nicardipine, nifedipine)	Increased concentrations of calcium-channel blocking agents 1	Use concomitantly with caution; clinical monitoring recommended1
Cisapride	Potential for serious and/or life-threatening effects such as cardiac arrhythmias 1	Concomitant use contraindicated1
Clarithromycin	Increased clarithromycin concentrations1	Modification of usual clarithromycin dosage not necessary in patients with normal renal function; reduce clarithromycin dosage by 50% if Clcr 30–60 mL/minute and reduce by 75% if Clcr <30 mL/minute 1
Corticosteroids (dexamethasone, fluticasone)	Fluticasone nasal spray/oral inhalation: Increased fluticasone concentrations with ritonavir-boosted darunavir resulting in decreased cortisol concentrations1 4 Dexamethasone: Decreased darunavir concentration; possible decreased antiretroviral efficacy1	Fluticasone nasal spray/oral inhalation: Consider alternatives to fluticasone, especially when long-term corticosteroid use anticipated1 4
Delavirdine	No in vitro evidence of antagonistic antiretroviral effects 1
Didanosine	Didanosine delayed-release capsules: No change in didanosine or darunavir concentrations1 Conflicting administration instructions with didanosine and food1 No in vitro evidence of antagonistic antiretroviral effects 1	Administer darunavir with low-dose ritonavir (with food) 1 hour after or 2 hours before didanosine (without food)1
Digoxin	Increased digoxin concentrations1	Use lowest possible initial dose of digoxin; monitor digoxin concentrations and adjust dose as clinically indicated1
Dextromethorphan	Increased dextromethorphan concentrations1
Efavirenz	Decreased darunavir AUC; increased efavirenz AUC1 4 No in vitro evidence of antagonistic antiretroviral effects 1	Clinical importance unknown4 Some experts suggest usual dosages can be used with close monitoring; consider monitoring plasma darunavir and efavirenz concentrations4
Emtricitabine	Pharmacokinetic interaction not expected1 No in vitro evidence of antagonistic antiretroviral effects 1
Etravirine	Decrease in AUC of etravirine; no change in darunavir concentrations; safety and efficacy of ritonavir-boosted darunavir and etravirine established in clinical studies1 4	Dosage adjustment not needed1 4
Enfuvirtide	No in vitro evidence of antagonistic antiretroviral effects1
Ergot alkaloids (dihydroergotamine, ergonovine, ergotamine, methylergonovine)	Potential for serious or life-threatening adverse effects (e.g., peripheral vasospasm, ischemia of extremities)1	Concomitant use contraindicated 1 If treatment of uterine atony and excessive postpartum bleeding is indicated in a woman receiving darunavir, use methylergonovine maleate (Methergine) only if alternative treatments cannot be used and if potential benefits outweigh risks; use methylergonovine at lowest dosage and shortest duration possible7
Fosamprenavir	Data not available regarding pharmacokinetic interaction1	Concomitant use not recommended pending further data1
Histamine H2- receptor antagonists (e.g., ranitidine)	Ranitidine: Pharmacokinetic interaction not expected1 4	Dosage adjustment not necessary1
HMG-CoA reductase inhibitors	Lovastatin, simvastatin: Increased risk of serious adverse reactions (e.g., myopathy, rhabdomyolysis)1 Increased concentrations of certain HMG-CoA reductase inhibitors (i.e., atorvastatin, pravastatin, rosuvastatin)1 4	Concomitant use with lovastatin or simvastatin contraindicated1 If used with atorvastatin, pravastatin, or rosuvastatin, use lowest possible dosage of the HMG-CoA reductase inhibitor and monitor carefully; consider using fluvastatin1
Hormonal contraceptives (estrogens or progestins)	Decreased ethinyl estradiol and norethindrone concentrations with oral contraceptive preparations1	Use alternative nonhormonal contraception methods1
Immunosuppressive agents (cyclosporine, sirolimus, tacrolimus)	Potential for increased immunosuppressive agent concentrations1	Monitor plasma concentrations of immunosuppressive agent if used concomitantly1
Indinavir	Increased darunavir and indinavir concentrations1 No in vitro evidence of antagonistic antiretroviral effects1	Appropriate dosages for concomitant use not established1
Lamivudine	Pharmacokinetic interaction unlikely1 No in vitro evidence of antagonistic antiretroviral effects1
Lopinavir	No change in lopinavir concentrations; decreased darunavir concentrations1 No in vitro evidence of antagonistic antiretroviral effects1	Concomitant use not recommended1 4
Maraviroc	Increased maraviroc concentrations4	Recommended dosage of maraviroc is 150 mg twice daily when used with ritonavir-boosted darunavir4
Methadone	Decreased methadone concentrations1	Adjustment in the methadone dosage not needed; closely monitor for signs of opiate withdrawal and adjust methadone dosage if needed1
Nelfinavir	Data not available regarding pharmacokinetic interaction1 No in vitro evidence of antagonistic antiretroviral effects1	Concomitant use not recommended pending further data1
Nevirapine	Increased plasma nevirapine concentrations; unchanged plasma darunavir concentrations1 4 No in vitro evidence of antagonistic antiretroviral effects1	Dosage adjustment not necessary1 4
Proton pump inhibitors	Omeprazole: Decreased omeprazole concentrations1	Dosage adjustment not necessary1
Psychotherapeutic agents (e.g., desipramine, pimozide, risperidone, thioridazine, trazodone, SSRIs)	Pimozide: Potential for serious and/or life-threatening adverse effects (e.g., cardiac arrhythmias)1 Desipramine, trazodone: Potential for increased concentrations of the antidepressant; 1 increased risk of nausea, dizziness, hypotension, syncope1 SSRIs: Decreased concentrations of paroxetine and sertraline; unchanged darunavir concentrations1 4 Risperidone, thioridazine: Potential for increased concentrations of the psychotherapeutic agent1	Pimozide: Concomitant use contraindicated1 Desipramine, trazodone: Caution; reduced dosage of the antidepressant may be needed1 SSRIs: Titrate dosage of paroxetine or sertraline and monitor for clinical response1 4 Risperidone, thioridazine: Reduced dosage of the psychotherapeutic agent may be needed1
Ritonavir	Increased plasma darunavir concentrations and AUC;1 2 4 concomitant low-dose ritonavir used to therapeutic advantage (ritonavir-boosted darunavir)1 2 4 No in vitro evidence of antagonistic antiretroviral effects1
St. John’s wort (Hypericum perforatum)	Potential decreased darunavir concentration; possible decreased antiretroviral efficacy1	Concomitant use contraindicated1
Saquinavir	Decreased darunavir concentrations; unchanged saquinavir concentrations1 No in vitro evidence of antagonistic antiretroviral effects1	Concomitant use not recommended1 4
Sildenafil	Possible increased sildenafil concentrations and increased risk of sildenafil-associated adverse effects (e.g., hypotension, visual changes, prolonged erection)1	Do not exceed sildenafil dosage of 25 mg once every 48 hours; closely monitor for adverse effects (e.g., hypotension, syncope, visual changes, prolonged erection)1 4
Stavudine	Pharmacokinetic interaction unlikely1 No in vitro evidence of antagonistic antiretroviral effects1
Tadalafil	Possible increased tadalafil concentrations and increased risk of tadalafil-associated adverse effects (e.g., hypotension, visual changes, prolonged erection)1	Use with caution and with reduced tadalafil dosage (initial dosage of 5 mg and do not exceed a single dose of 10 mg in 72 hours);4 closely monitor for adverse effects1 4
Tenofovir	Increased plasma tenofovir concentrations; unchanged plasma darunavir concentrations1 4 No in vitro evidence of antagonistic antiretroviral effects1	Manufacturer of darunavir recommends usual dosage of tenofovir with ritonavir-boosted darunavir 1 Some experts state clinical importance unknown; monitor for tenofovir toxicity4
Tipranavir	No in vitro evidence of antagonistic antiretroviral effects 1	Concomitant use not recommended1
Vardenafil	Possible increased vardenafil concentrations and increased risk of vardenafil-associated adverse effects (e.g., hypotension, visual changes, prolonged erection)1	Do not exceed vardenafil dosage of 2.5 mg once every 72 hours; closely monitor for adverse effects (e.g., hypotension, syncope, visual changes, prolonged erection)1 4
Zidovudine	Pharmacokinetic interaction unlikely1 No in vitro evidence of antagonistic antiretroviral effects1

Prezista Pharmacokinetics

Absorption

Bioavailability

Darunavir administered concomitantly with low-dose ritonavir (ritonavir-boosted darunavir).¹ Ritonavir decreases metabolism of darunavir, resulting in increased plasma darunavir concentrations.¹

Peak plasma darunavir concentrations attained approximately 2.5–4 hours after a dose.¹

Food

Compared with administration in the fasting state, administration of ritonavir-boosted darunavir with food increases peak darunavir concentrations and AUC approximately 30%.¹

Distribution

Extent

Not known whether distributed into human milk;¹ distributed into milk in rats.¹

Plasma Protein Binding

95%.¹

Binds principally to α₁-acid-glycoprotein.¹

Elimination

Metabolism

Darunavir extensively metabolized by CYP3A.¹

Elimination Route

Following administration of ritonavir-boosted darunavir, eliminated principally in feces as unchanged darunavir.¹ Approximately 80% of darunavir dose excreted in feces and 14% excreted in urine.¹

Half-life

15 hours.¹

Special Populations

Moderate renal impairment (Cl_cr 30–60 mL/minute): Pharmacokinetics not affected.¹

Severe renal impairment or end-stage renal disease: No pharmacokinetic data.¹

Unlikely to be removed by hemodialysis or peritoneal dialysis.¹

Hepatic impairment: Pharmacokinetics in individuals with mild hepatic impairment (Child-Pugh class A) or moderate hepatic impairment (Child-Pugh class B) similar to values in individuals with normal hepatic function.¹ Pharmacokinetics not evaluated in those with severe hepatic impairment.¹

HBV or HCV coinfection: No effect on darunavir exposure.¹

Higher darunavir concentrations reported in females compared with males; dosage adjustments not required.¹

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

Actions and SpectrumActions

• 
  

  Darunavir is administered in conjunction with low-dose ritonavir (ritonavir-boosted darunavir).¹

  
  


• 
  

  Darunavir is extensively metabolized by CYP3A; ritonavir is a potent inhibitor of CYP3A.¹ Concomitant use of these drugs results in decreased metabolism and increased plasma concentrations of darunavir.¹

  
  


• 
  

  Antiretroviral activity is due to darunavir.¹

  
  


• 
  

  Active against HIV-1.¹

  
  


• 
  

  Darunavir inhibits replication of HIV-1 by interfering with HIV proteases.¹

  
  


• 
  

  Darunavir-resistant HIV-1, including strains with decreased susceptibility to other PIs, has been reported.^{1 3}

  
  

Advice to Patients

• 
  

  Critical nature of compliance with HIV therapy.¹ Importance of using darunavir with low-dose ritonavir; importance of using these 2 drugs in conjunction with other antiretrovirals.¹

  
  


• 
  

  Antiretroviral therapy is not a cure for HIV infection, and opportunistic infections still may occur.¹ HIV transmission via sexual contact or sharing needles is not prevented by antiretrovirals.¹

  
  


• 
  

  Importance of reading patient information provided by the manufacturer.¹

  
  


• 
  

  Importance of taking darunavir with food and at the same time as ritonavir.¹ Importance of swallowing the darunavir tablets whole with a drink (e.g., water, milk); the tablets should not be chewed.¹ If also taking didanosine, administer didanosine dose 1 hour before or 2 hours after ritonavir-boosted darunavir.¹

  
  


• 
  

  If a dose of darunavir or ritonavir is missed by <6 hours, administer the dose as soon as it is remembered and the next dose at the regularly scheduled time.¹ If a dose of darunavir or ritonavir is missed by >6 hours, omit the dose and administer the next dose at the regularly scheduled time.¹ Do not administer a double dose to make up for a missed dose.¹

  
  


• 
  

  Importance of patient informing their clinician if they are allergic to sulfonamides.¹

  
  


• 
  

  Redistribution/accumulation of body fat may occur with antiretroviral therapy, with as yet unknown long-term health effects.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal products (e.g., St. John’s wort), and any concomitant illnesses.¹

  
  


• 
  

  Advise patients receiving selective phosphodiesterase (PDE) inhibitors (e.g., sildenafil, tadalafil, vardenafil) that they may be at increased risk of PDE inhibitor-associated adverse effects (e.g., hypotension, visual changes, priapism) and that any symptoms should be promptly reported to their clinician.¹

  
  


• 
  

  Importance of women using a reliable nonhormonal (e.g., barrier) method of contraception because of the potential interaction with hormonal contraceptives.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Darunavir (Ethanolate)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	75 mg (of darunavir)	Prezista	Tibotec
		150 mg (of darunavir)	Prezista	Tibotec
		400 mg (of darunavir)	Prezista	Tibotec
		600 mg (of darunavir)	Prezista	Tibotec

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Prezista 400MG Tablets (CENTOCOR ORTHO BIOTECH PRODUCT): 60/$1060.01 or 120/$2120.03

Prezista 600MG Tablets (CENTOCOR ORTHO BIOTECH PRODUCT): 60/$1100.02 or 180/$3109.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Tibotec. Prezista (darunavir) prescribing information. Raritan, NJ; 2008 Dec.

2. Koh Y, Nakata H, Maeda K et al. Novel bis-tetrahydrofuranylurethane-containing nonpeptidic protease inhibitor (PI) UIC-94017 (TMC114) with potent activity against multi-PI-resistant human immunodeficiency virus in vitro. Antimicrob Agents Chemother. 2003; 47:3123-9. [PubMed 14506019]

3. De Meyer S, Azijn H, Surleraux D et al. TMC114, a novel human immunodeficiency virus type 1 protease inhibitor active against protease inhibitor-resistant viruses, including a broad range of clinical isolates. Antimicrob Agents Chemother. 2005; 49:2314-21. [PubMed 15917527]

4. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (November 3, 2008). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website ().

5. Hammer SM, Saag MS, Schechter M, et al. Treatment of adult HIV infection: 2006 recommendations of the International AIDS Society–USA panel. JAMA. 2006; 296:827-43. [PubMed 16905788]

6. Banhegyi D, Esser S, Opravil M, Lefebvre E. TMC114/r outperforms investigator-selected PI(s) in treatment-experienced patients: 24-week primary efficacy and safety analysis of POWER 1. 1st European and Central Asian AIDS conference , Moscow, Russia, 2006 May 15–17. Poster. From Tibotec website ().

7. Perinatal HIV Guidelines Working Group. Public Health Service task force recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States (April 29, 2009). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website ().

8. Working Group on Antiretroviral Therapy and Medical Management of HIV-infected Children of the National Resource Center at the François-Xavier Bagnoud Center, Health Resources and Services Administration (HRSA), and National Institutes of Health (NIH). Guidelines for the use of antiretroviral agents in pediatric HIV infection (February 23, 2009). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website ().

9. Madruga JV, Berger D, McMurchie M et al. Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial. Lancet. 2007; 370:49-58. [PubMed 17617272]

10. Ortiz R, DeJesus E, Khanlou H et al. Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1 infected patients at week 48. AIDS. 2008; 22:1389-97. [PubMed 18614861]

11. Tibotec Therapeutics. Intelence (etravirine) tablets prescribing information. Raritan, NJ; 2008 Jan.

More Prezista resources

• Prezista Side Effects (in more detail)
• Prezista Use in Pregnancy & Breastfeeding
• Prezista Drug Interactions
• Prezista Support Group
• 3 Reviews for Prezista - Add your own review/rating

• Prezista Prescribing Information (FDA)


• Prezista Advanced Consumer (Micromedex) - Includes Dosage Information


• Prezista MedFacts Consumer Leaflet (Wolters Kluwer)


• Prezista Consumer Overview

Compare Prezista with other medications

• HIV Infection

PrimaCare One

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are PrimaCare One (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins side effects

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

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

• 
  

  upset stomach;

  
  


• 
  

  headache; or

  
  


• 
  

  unusual or unpleasant taste in your mouth.

  
  

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.

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

• 
  

  diuretics (water pills);

  
  


• 
  

  heart or blood pressure medications;

  
  


• 
  

  tretinoin (Vesanoid);

  
  


• 
  

  isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

  
  


• 
  

  trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More PrimaCare One resources

• PrimaCare One Side Effects (in more detail)
• PrimaCare One Use in Pregnancy & Breastfeeding
• Drug Images
• PrimaCare One Drug Interactions
• PrimaCare One Support Group
• 0 Reviews for PrimaCare One - Add your own review/rating

• PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)


• Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)


• CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal Assure Prescribing Information (FDA)


• CitraNatal Harmony Prescribing Information (FDA)


• Concept DHA Prescribing Information (FDA)


• Docosavit Prescribing Information (FDA)


• Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)


• Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)


• Folcal DHA Prescribing Information (FDA)


• Folcaps Care One Prescribing Information (FDA)


• Gesticare DHA Prescribing Information (FDA)


• Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• Inatal Advance Prescribing Information (FDA)


• Inatal Ultra Prescribing Information (FDA)


• Multi-Nate DHA Prescribing Information (FDA)


• Multi-Nate DHA Extra Prescribing Information (FDA)


• MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)


• Natelle One Prescribing Information (FDA)


• Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)


• Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)


• Paire OB Plus DHA Prescribing Information (FDA)


• PreNexa Prescribing Information (FDA)


• PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)


• PreferaOB Prescribing Information (FDA)


• Prenatal Plus Prescribing Information (FDA)


• Prenatal Plus Iron Prescribing Information (FDA)


• Prenate Elite Prescribing Information (FDA)


• Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)


• Prenate Elite tablets


• Prenate Essential Prescribing Information (FDA)


• PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)


• PrimaCare ONE capsules


• Renate DHA Prescribing Information (FDA)


• Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Se-Natal 19 Prescribing Information (FDA)


• Tandem DHA Prescribing Information (FDA)


• Tandem OB Prescribing Information (FDA)


• TriAdvance Prescribing Information (FDA)


• Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Triveen-PRx RNF Prescribing Information (FDA)


• UltimateCare ONE NF Prescribing Information (FDA)


• Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)


• Vinate AZ Prescribing Information (FDA)


• Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Zatean-CH Prescribing Information (FDA)

Compare PrimaCare One with other medications

• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

• Your pharmacist can provide more information about prenatal vitamins.

See also: PrimaCare One side effects (in more detail)

primaquine

Generic Name: primaquine (PRIM a kwin)

Brand Names:

What is primaquine?

Primaquine is an antimalarial drug. The exact way that primaquine works is unknown.

Primaquine is used to treat and prevent malaria.

Primaquine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about primaquine?

Notify your doctor if your urine turns dark.

Use caution when driving or performing other hazardous activities until you know how this medication affects you. Primaquine may cause visual disturbances such as blurred vision, misty vision, and difficulty focusing. Report any vision or hearing changes to your doctor.

Who should not take primaquine?

Before taking this medication, tell your doctor if you have

• 
  

  a history of an allergic reaction to previous primaquine therapy,

  
  


• 
  

  glucose-6-phosphate dehydrogenase (G-6-PD) deficiency,

  
  


• 
  

  rheumatoid arthritis,

  
  


• 
  

  lupus erythematosus, or

  
  


• 
  

  quinacrine (Atabrine) therapy.

  
  

You may not be able to take primaquine, or you may require a lower dose or special monitoring during your therapy if you have any of the conditions listed above.

It is not known whether primaquine will harm an unborn baby. Do not take primaquine without first talking to your doctor if you are pregnant. It is not known how primaquine will affect a nursing baby. Do not take primaquine without first talking to your doctor if you are breast-feeding a baby.

How should I take primaquine?

Take primaquine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take primaquine with food to lessen stomach upset. Store primaquine at room temperature away from moisture and heat.

See also: Primaquine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and only take your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a primaquine overdose include nausea, vomiting, stomach upset, and stomach cramps.

What should I avoid while taking primaquine?

Use caution when driving or performing other hazardous activities until you know how this medication affects you. Primaquine may cause visual disturbances such as blurred vision, misty vision, and difficulty focusing. Report any vision or hearing changes to your doctor.

Primaquine side effects

Stop taking primaquine and seek emergency medical attention if you experience an allergic reaction (flushing; swelling of your lips, tongue, or face, difficulty breathing; closing of your throat; vision problems; a rash; or itching).

Notify your doctor if you experience darkening of your urine.

Nausea, stomach pain or upset, vomiting, and loss of appetite may also occur during therapy.

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.

Primaquine Dosing Information

Usual Adult Dose for Malaria:

Manufacturer recommendation: 15 mg base (26.3 mg salt) orally once a day for 14 days

Centers for Disease Control and Prevention (CDC) recommendation: 30 mg base (52.6 mg salt) orally once a day for 14 days; for patients with borderline glucose-6-phosphate dehydrogenase (G6PD) deficiency or as an alternative regimen, 45 mg base (78.9 mg salt) orally once a week for 8 weeks has been recommended

Usual Adult Dose for Malaria Prophylaxis:

Primary prophylaxis of malaria (including chloroquine-resistant malaria):
CDC recommendation: 30 mg base (52.6 mg salt) orally once a day

Primaquine should be taken 1 to 2 days before travel to malarious areas, while in such areas, and for 7 days after leaving the areas. It is generally used for short-duration travel to areas with primarily P vivax.

Terminal prophylaxis of P vivax or P ovale malaria:
Manufacturer recommendation: 15 mg base (26.3 mg salt) orally once a day for 14 days
CDC recommendation: 30 mg base (52.6 mg salt) orally once a day for 14 days

Usual Adult Dose for Pneumocystis Pneumonia:

15 to 30 mg base (26.3 to 52.6 mg salt) orally once a day for 21 days; effective in combination with clindamycin

Primaquine plus clindamycin is recommended as an alternative regimen by the CDC, National Institutes of Health (NIH), and Infectious Diseases Society of America (IDSA). Seriously ill patients should receive IV trimethoprim-sulfamethoxazole or pentamidine therapy.

Usual Pediatric Dose for Malaria:

Manufacturer recommendation: 0.3 mg/kg base (0.526 mg/kg salt) orally once a day for 14 days (not to exceed 15 mg base/day)

CDC recommendation: 0.5 mg/kg base (0.88 mg/kg salt) orally once a day for 14 days (not to exceed 30 mg base/day); for patients with borderline G6PD deficiency or as an alternative regimen, 0.75 mg/kg base (1.3 mg/kg salt) orally once a week for 8 weeks (not to exceed 45 mg base/week) has been recommended

Usual Pediatric Dose for Malaria Prophylaxis:

Primary prophylaxis of malaria (including chloroquine-resistant malaria):
CDC recommendation: 0.5 mg/kg base (0.88 mg/kg salt) orally once a day (not to exceed 30 mg base/day)

Primaquine should be taken 1 to 2 days before travel to malarious areas, while in such areas, and for 7 days after leaving the areas. It is generally used for short-duration travel to areas with primarily P vivax.

Terminal prophylaxis of P vivax or P ovale malaria:
Manufacturer recommendation: 0.3 mg/kg base (0.526 mg/kg salt) orally once a day for 14 days (not to exceed 15 mg base/day)
CDC recommendation: 0.5 mg/kg base (0.88 mg/kg salt) orally once a day for 14 days (not to exceed 30 mg base/day)

Usual Pediatric Dose for Pneumocystis Pneumonia:

0.3 mg/kg base (0.526 mg/kg salt) orally once a day for 21 days (not to exceed 30 mg base/day); effective in combination with clindamycin

Primaquine plus clindamycin is recommended as an alternative regimen by the CDC, NIH, IDSA, Pediatric Infectious Diseases Society, and American Academy of Pediatrics. Seriously ill patients should receive IV trimethoprim-sulfamethoxazole or pentamidine therapy.

What other drugs will affect primaquine?

Do not take primaquine if you have recently taken quinacrine (Atabrine). These two drugs are similar and can cause dangerous side effects if they are taken together.

Drugs other than those listed here may also interact with primaquine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More primaquine resources

• Primaquine Side Effects (in more detail)
• Primaquine Dosage
• Primaquine Use in Pregnancy & Breastfeeding
• Primaquine Drug Interactions
• Primaquine Support Group
• 0 Reviews for Primaquine - Add your own review/rating

• primaquine Advanced Consumer (Micromedex) - Includes Dosage Information


• Primaquine MedFacts Consumer Leaflet (Wolters Kluwer)


• Primaquine Prescribing Information (FDA)


• Primaquine Phosphate Monograph (AHFS DI)

Compare primaquine with other medications

• Malaria
• Malaria Prevention
• Pneumocystis Pneumonia

Where can I get more information?

• Your pharmacist can provide more information about primaquine.

See also: primaquine side effects (in more detail)