Trimox Suspension

Pronunciation: a-MOX-i-SIL-in
Generic Name: Amoxicillin
Brand Name: Generic only. No brands available.

Trimox Suspension is used for:

Treating infections caused by certain bacteria. It is also used with other medicines to treat Helicobacter pylori infection and ulcers of the small intestines.

Trimox Suspension is a penicillin antibiotic. It works by killing sensitive bacteria.

Do NOT use Trimox Suspension if:

• you are allergic to any ingredient in Trimox Suspension or another penicillin antibiotic (eg, ampicillin)


• you have recently received or will be receiving live oral typhoid vaccine


• you have infectious mononucleosis (mono)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Trimox Suspension:

Some medical conditions may interact with Trimox Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of allergies, asthma, hay fever, or hives


• if you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to a cephalosporin (eg, cephalexin) or another beta-lactam antibiotic (eg, imipenem)


• if you have kidney problems or gonorrhea

Some MEDICINES MAY INTERACT with Trimox Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin) because the risk of bleeding may be increased


• Probenecid because it may increase the amount of Trimox Suspension in your blood


• Chloramphenicol, macrolide antibiotics (eg, erythromycin), sulfonamides (eg, sulfamethoxazole), or tetracycline antibiotics (eg, doxycycline) because they may decrease Trimox Suspension's effectiveness


• Methotrexate because the risk of its side effects may be increased by Trimox Suspension


• Live oral typhoid vaccine or hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by Trimox Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Trimox Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Trimox Suspension:

Use Trimox Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Trimox Suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Shake well before each use.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Trimox Suspension may be mixed with formula, milk, fruit juice, water, ginger ale, or other cold drinks. If you mix Trimox Suspension, take it at once after mixing. Be sure that the entire dose is swallowed.


• To clear up your infection completely, take Trimox Suspension for the full course of treatment. Keep taking it even if you feel better in a few days.


• If you miss a dose of Trimox Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Trimox Suspension.

Important safety information:

• Trimox Suspension may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Trimox Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Trimox Suspension only works against bacteria; it does not treat viral infections (eg, the common cold).


• Be sure to use Trimox Suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Trimox Suspension may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Trimox Suspension. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Brown, yellow, or gray tooth discoloration has occurred rarely in some patients taking Trimox Suspension. It occurred most often in children. The discoloration was reduced or removed by brushing or dental cleaning in most cases. Contact your doctor if you experience this effect.


• Diabetes patients - Trimox Suspension may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.


• Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed if you use Trimox Suspension for a long period of time. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Trimox Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially patients with kidney problems.


• Use Trimox Suspension with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.


• Caution is advised when using Trimox Suspension in CHILDREN younger than 3 months old; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Trimox Suspension while you are pregnant. Trimox Suspension is found in breast milk. If you are or will be breast-feeding while you use Trimox Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Trimox Suspension:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; confusion; dark urine; fever, chills, or persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; stomach pain or cramps; unusual bruising or bleeding; vaginal discharge or irritation; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Trimox side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination.

Proper storage of Trimox Suspension:

Store Trimox Suspension in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. If necessary, it may be stored at room temperature. Store away from heat, moisture, and light. Do not store in the bathroom. Throw away any unused medicine after 14 days. Keep Trimox Suspension out of reach of children and away from pets.

General information:

• If you have any questions about Trimox Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Trimox Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Trimox Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Trimox resources

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

Compare Trimox with other medications

• Actinomycosis
• Anthrax Prophylaxis
• Bacterial Endocarditis Prevention
• Bacterial Infection
• Bladder Infection
• Bronchitis
• Chlamydia Infection
• Cutaneous Bacillus anthracis
• Dental Abscess
• Helicobacter Pylori Infection
• Lyme Disease, Arthritis
• Lyme Disease, Carditis
• Lyme Disease, Erythema Chronicum Migrans
• Lyme Disease, Neurologic
• Otitis Media
• Pneumonia
• Sinusitis
• Skin Infection
• Tonsillitis/Pharyngitis
• Upper Respiratory Tract Infection
• Urinary Tract Infection

Pilocarpine Eye Drops

Dosage Form: ophthalmic solution
FULL PRESCRIBING INFORMATION

Indications and Usage for Pilocarpine Eye Drops

Pilocarpine Hydrochloride Ophthalmic Solution is indicated for the:

Reduction of Elevated Intraocular Pressure (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension

Management of Acute Angle-Closure Glaucoma

Prevention of Postoperative Elevated IOP Associated with Laser Surgery

Induction of Miosis

Pilocarpine Eye Drops Dosage and Administration

Reduction of Elevated Intraocular Pressure (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension

One drop of Pilocarpine Hydrochloride Ophthalmic Solution 1%, 2% or 4% should be applied topically in the eye(s) up to four times daily.

Pilocarpine-naïve patients should be started on the 1% concentration as higher concentrations are often not tolerated initially. The frequency of instillation and concentration of Pilocarpine Hydrochloride Ophthalmic Solution are determined by the severity of the elevated intraocular pressure and miotic response of the patient. To limit systemic exposure to pilocarpine, patients may be instructed to perform punctal occlusion for 2 minutes after instillation of Pilocarpine Hydrochloride Ophthalmic Solution.

Management of Acute Angle-Closure Glaucoma

Prior to Pilocarpine Hydrochloride Ophthalmic Solution use, treatment with secretory suppressants and hyperosmotic agents may be needed to lower IOP below 50 mmHg and relieve iris ischemia.

For initial management of acute angle-closure glaucoma, one drop of Pilocarpine Hydrochloride Ophthalmic Solution 1% or 2% may be applied topically in the eye(s) up to three times over a 30-minute period.

If laser iridoplasty or iridomy is used to break the attack, one drop of Pilocarpine Hydrochloride Ophthalmic Solution 4% should be administered prior to the procedure. Following laser iridoplasty, one drop of Pilocarpine Hydrochloride Ophthalmic Solution 1% should be administered four times daily until an iridotomy can be performed.

Prevention of Postoperative Elevated IOP Associated with Laser Surgery

One drop of Pilocarpine Hydrochloride Ophthalmic Solution 1%, 2% or 4% (or two drops administered five minutes apart) should be applied topically in the eye(s) 15 to 60 minutes prior to surgery.

Induction of Miosis

One drop of Pilocarpine Hydrochloride Ophthalmic Solution 1%, 2% or 4% (or two drops administered five minutes apart) should be applied topically in the eye(s).

Use with Other Topical Ophthalmic Medications

Pilocarpine may be used in combination with beta-blockers, carbonic anhydrase inhibitors, sympathomimetics or hyperosmotic agents. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

Use in Pediatric Patients

In children under 2 years of age, one drop of Pilocarpine Hydrochloride Ophthalmic Solution 1% should be applied topically in the eye(s) three times daily. Children 2 years of age and over should be dosed as for adults. For the induction of miosis prior to goniotomy or trabeculotomy in children, one drop of Pilocarpine Hydrochloride Ophthalmic Solution 1% or 2% should be applied topically in the eye 15 to 60 minutes prior to surgery.

Dosage Forms and Strengths

Bottle filled with 15 mL of 1% (10 mg/mL), 2% (20 mg/mL) or 4% (40 mg/mL) pilocarpine hydrochloride sterile ophthalmic solution.

Contraindications

None.

Warnings and Precautions

Poor Illumination

Patients should be advised to exercise caution in night driving and other hazardous occupations in poor illumination. In addition, miotics may cause accommodative spasm. Patients should be advised not to drive or use machinery if vision is not clear.

Pre-existing Retinal Disease

As with all miotics, rare cases of retinal detachment have been reported when used in certain susceptible individuals and those with pre-existing retinal disease; therefore, a thorough examination of the retina including funduscopy is advised in all patients prior to the initiation of therapy.

Iritis

Pilocarpine Hydrochloride Ophthalmic Solution is not recommended to be used when iritis is present.

Primary Congenital Glaucoma

Caution is advised when using Pilocarpine Hydrochloride Ophthalmic Solution in pediatric patients with primary congenital glaucoma for control of intraocular pressure (IOP) as cases of a paradoxical increase in IOP have been reported. In addition, the use of Pilocarpine Hydrochloride Ophthalmic Solution is not recommended in pediatric patients diagnosed with glaucoma secondary to anterior segment dysgenesis or uveitis (especially if uveitis is active).

Contact Lens Wear

Contact lens wearers should be advised to remove their lenses prior to the instillation of Pilocarpine Hydrochloride Ophthalmic Solution and to wait 10 minutes after dosing before reinserting their contact lenses.

Adverse Reactions

Clinical Studies 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 safety data described below reflect exposure in four controlled clinical trials of 90 days to 2 years duration in 317 patients diagnosed with open-angle glaucoma or ocular hypertension. In the four clinical trials, patients were treated with Pilocarpine Hydrochloride Ophthalmic Solution 2%, two to four times daily or with Pilocarpine Hydrochloride Ophthalmic Solution 1%, 1.75% or 2% in fixed combination with betaxolol 0.25%, two or three times daily. The most frequently reported adverse reactions occurring in ≥ 5% of patients in the pilocarpine 2% populations were: headache/browache, accommodative change, blurred vision, eye irritation, visual impairment (dim, dark, or "jumping" vision), and eye pain.

The adverse reaction profile reported for the use of Pilocarpine Hydrochloride Ophthalmic Solution in pediatric patients is comparable to that seen in adult patients.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy. Category C. Animal reproduction studies have not been conducted with pilocarpine hydrochloride. It is also not known whether pilocarpine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pilocarpine Hydrochloride Ophthalmic Solution should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Pilocarpine Hydrochloride Ophthalmic Solution is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of pilocarpine hydrochloride ophthalmic solution in pediatric patients have been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Overdosage

Systemic toxicity following topical ocular administration of pilocarpine is rare, but occasionally patients who are sensitive may develop sweating and gastrointestinal overactivity following the suggested dosage and administration. Overdosage can produce sweating, salivation, nausea, tremors and slowing of the pulse and a decrease in blood pressure. In moderate overdosage, spontaneous recovery is to be expected and is aided by intravenous fluids to compensate for dehydration. For patients demonstrating severe poisoning, atropine, the pharmacologic antagonist to pilocarpine, should be used.

Pilocarpine Eye Drops Description

Pilocarpine Hydrochloride Ophthalmic Solution is a cholinergic agonist prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure:

Established name: pilocarpine hydrochloride Chemical name: 2(3H)-furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)-methyl]- monohydrochloride, (3S-cis)-. Molecular Formula: C11H16N2O2 • HCl. Molecular Weight: 244.72.

Each mL of Pilocarpine Hydrochloride Ophthalmic Solution contains: Active: pilocarpine hydrochloride 1% (10 mg/mL), 2% (20 mg/mL), or 4% (40 mg/mL). Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 2910, boric acid, sodium citrate, sodium chloride (present in 1% only); hydrochloric acid and/or sodium hydroxide (to adjust pH); purified water. Pilocarpine Hydrochloride Ophthalmic Solution has a pH of 3.5 to 5.5 and an osmolality of 290 to 350 mOsm/kg (1% and 2% products) and 550 to 600 mOsm/kg (4% product).

Pilocarpine Eye Drops - Clinical Pharmacology

Mechanism of Action

Pilocarpine hydrochloride is a direct acting cholinergic parasympathomimetic agent which acts through direct stimulation of muscarinic receptors and smooth muscle such as the iris and secretory glands.

Pilocarpine contracts the ciliary muscle, causing increased tension on the scleral spur and opening of the trabecular meshwork spaces to facilitate outflow of aqueous humor. Outflow resistance is reduced, lowering intraocular pressure (IOP). Pilocarpine also produces miosis through contraction of the iris sphincter muscle. Miosis relieves appositional angle narrowing and closure, which lowers IOP in certain types of angle-closure glaucoma.

Pharmacokinetics

Systemic exposure to pilocarpine was evaluated in 14 healthy subjects administered 2 drops of pilocarpine hydrochloride ophthalmic solution 4% to both eyes four times daily for eight days. A comparison of Cmax values on Days 5 and 8 indicated that pilocarpine concentrations in plasma reached steady-state following topical administration of Pilocarpine Hydrochloride Ophthalmic Solution 4%. The mean (SD) Cmax and AUC0-last values on Day 8 were 3.7 (3.2) ng/mL and 7.7 (8.4) ngxhour/mL, respectively. The Tmax values on Day 8 ranged from 0.5 to 1 hour.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

There have been no long-term studies done using pilocarpine hydrochloride in animals to evaluate carcinogenic potential.

Clinical Studies

In clinical trials reported in the medical literature, pilocarpine ophthalmic solution reduced intraocular pressure (IOP) by 3-7 mmHg in patients with open-angle glaucoma. Pilocarpine ophthalmic solution has also been shown to be effective in the induction of miosis, in the prevention of postoperative elevated IOP, and in the management of acute angle-closure glaucoma.

How Supplied/Storage and Handling

Pilocarpine Hydrochloride Ophthalmic Solution 1%, 2% and 4% is supplied sterile in natural low density polyethylene plastic ophthalmic DROP-TAINER®* dispensers and green low density polyethylene tips with green polypropylene caps.

15 mL in 15 mL bottles

1%: NDC 61314-203-15

2%: NDC 61314-204-15

4%: NDC 61314-206-15

STORAGE: Store at 15°- 25°C (59° - 77°F) and protect from freezing.

Patient Counseling Information

Avoiding Contamination of the Product

Do not touch dropper tip to any surface, as this may contaminate the contents.

Night Driving

Caution is advised with night driving and when hazardous activities are undertaken in poor illumination.

Accommodative Spasm

Pilocarpine Hydrochloride Ophthalmic Solution may cause problems when changing focus between near objects and distant objects. Do not drive or use machinery if vision is not clear.

Contact Lens Wear

Contact lens should be removed prior to the instillation of Pilocarpine Hydrochloride Ophthalmic Solution. Wait 10 minutes after dosing before reinserting contact lenses.

Concomitant Topical Ocular Therapy

If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart.

Systemic Exposure

To limit exposure to pilocarpine to the eye alone, close eyes gently and apply pressure with finger to the corner of eye by the nose for 2 minutes after instillation of Pilocarpine Hydrochloride Ophthalmic Solution.

Rx Only

Printed in USA

*DROP-TAINER is a registered trademark of Alcon Research, Ltd.

      

Dist. By:

Falcon Pharmaceuticals, Ltd.

Fort Worth, Texas 76134 USA

Mfd. by:

Alcon Laboratories, Inc.

6201 South Freeway

Fort Worth, Texas 76134 USA

1-800-757-9195

         

9006010-1010

Principal Display Panel

NDC 61314-203-15           Rx Only

FALCON

PHARMACEUTICALS®

Pilocarpine

Hydrochloride

Ophthalmic

Solution

1%

15 mL STERILE

AFFILIATE OF           QUALITY RX

ALCON

LABORATORIES, INC.

PILOCARPINE HYDROCHLORIDE  pilocarpine hydrochloride  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 61314-203 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PILOCARPINE HYDROCHLORIDE (PILOCARPINE) PILOCARPINE HYDROCHLORIDE 10 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   HYPROMELLOSE 2910 (15 MPA.S)   BORIC ACID   SODIUM CITRATE   SODIUM CHLORIDE   HYDROCHLORIC ACID   SODIUM HYDROXIDE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 61314-203-15 15 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA200890	02/21/1996

PILOCARPINE HYDROCHLORIDE  pilocarpine hydrochloride  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 61314-204 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PILOCARPINE HYDROCHLORIDE (PILOCARPINE) PILOCARPINE HYDROCHLORIDE 20 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   HYPROMELLOSE 2910 (15 MPA.S)   BORIC ACID   SODIUM CITRATE   HYDROCHLORIC ACID   SODIUM HYDROXIDE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 61314-204-15 15 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA200890	02/21/1996

PILOCARPINE HYDROCHLORIDE  pilocarpine hydrochloride  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 61314-206 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PILOCARPINE HYDROCHLORIDE (PILOCARPINE) PILOCARPINE HYDROCHLORIDE 40 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   HYPROMELLOSE 2910 (15 MPA.S)   BORIC ACID   SODIUM CITRATE   HYDROCHLORIC ACID   SODIUM HYDROXIDE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 61314-206-15 15 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA200890	02/21/1996

Labeler - Falcon Pharmaceuticals, Ltd. (874345820)

Registrant - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Operations
Alcon Laboratories, Inc.		008018525	MANUFACTURE

Revised: 06/2011Falcon Pharmaceuticals, Ltd.

More Pilocarpine Eye Drops resources

• Pilocarpine Eye Drops Dosage
• Pilocarpine Eye Drops Use in Pregnancy & Breastfeeding
• Pilocarpine Eye Drops Drug Interactions
• Pilocarpine Eye Drops Support Group
• 0 Reviews for Pilocarpine Eye - Add your own review/rating

Compare Pilocarpine Eye Drops with other medications

• Glaucoma
• Intraocular Hypertension

Protium 40 mg i.v.

Protiumi.v.

Powder for Solution for Injection

Pantoprazole

What you should know about Protiumi.v.

Read the whole of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again


• If you have any further questions, ask your doctor or pharmacist


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours


• If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Protiumi.v. powder for solution for injection. In the rest of this leaflet your medicine is called Protiumi.v.

Protiumi.v. is one of a group of medicines called proton pump inhibitors, which work by reducing the amount of acid your stomach produces.

What is in your medicine?

What Protiumi.v. contains

The active substance in Protiumi.v. is pantoprazole. Each injection contains 40 mg of pantoprazole as pantoprazole sodium.

The other ingredients are edetate disodium dihydrate and sodium chloride.

What Protiumi.v. looks like

Protiumi.v. is a powder in a glass container with a rubber cap.

Contents of the pack

It comes in packs of 1, 5 and 20 containers.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Nycomed GmbH

Konstanz

Germany

Manufacturer:

Nycomed GmbH

Singen

Germany

Marketing Company:

Nycomed UK Ltd

Marlow

Buckinghamshire

UK

What is your injection for?

Protiumi.v. is used to treat ulcers in your stomach or intestine. It is used to treat and prevent acid rising from your stomach into your food pipe (oesophagus), which causes symptoms similar to severe heartburn. Protiumi.v. is used to treat conditions in which your stomach produces too much acid.

Before you are given your injection

Do not take Protiumi.v. if:

• You are allergic to pantoprazole or any of the other ingredients in Protiumi.v.


• If you are taking a medicine containing atazanavir (for the treatment of HIV-infection) at the same time.

Take special care with Protiumi.v. if:

• You think you have signs of stomach cancer. These include persistent weight loss, dark
  stools, loss of appetite, feeling full or a lump in your stomach”.

If the above statement applies to you, ask your doctor or pharmacist for advice before you take Protiumi.v.

Taking other medicines

Ask your doctor or pharmacist for advice before taking Protiumi.v. if you are taking any of the following medicines:

• Tablets containing ketoconazole, used to treat fungal infections of the skin and nails. Protiumi.v. may increase or decrease the effect of ketoconazole by altering the
  amount that gets into your body


• Medicines to thin your blood, such as warfarin, phenprocoumon or acenocoumarol.
  Protiumi.v. may alter the effect of these medicines. So your doctor may monitor how well your blood clots.


• Atazanavir, which is commonly used for the treatment of HIV infection. This is because
  Protium i.v. may decrease the amount of atazanavir that gets into your body.

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other
medicine – even those not prescribed.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking Protiumi.v.:

• If you are pregnant or planning to become pregnant


• If you are breast-feeding.

How is Protiumi.v. used?

Protiumi.v. is only used when you cannot take Protium tablets. Protiumi.v. is only for intravenous use (i.e. injection or infusion directly into a vein).

Protiumi.v. is supplied as a powder to which your doctor or nurse will add 10 ml of salt solution to make it into a liquid that can be injected. They may add more liquid, either a salt or sugar solution. This makes the medicine ready for you to have as an infusion (a slow injection lasting 2-15 minutes). Your doctor or nurse will give you Protiumi.v.

The usual dose is one 40 mg injection or infusion per day for up to one week. Your doctor will
switch from Protiumi.v. to Protium tablets as soon as possible.

If your stomach is producing too much acid, the usual starting dose is 80 mg per day. Your doctor will adjust the dose to match the amount of acid your stomach produces.

If you have liver problems, you should not take more than 20 mg of pantoprazole per day.

Protiumi.v. is not recommended for use in children under 18 years.

When your course of injections is finished, your doctor may prescribe further treatment with tablets.

What to do if you forget a dose, or take too many tablets

If you take more Protiumi.v. than you should, contact a doctor or nurse immediately.

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your
next dose. If it is, do not take the missed dose at all. Do not take two doses to make up for the one you have missed.

Do not stop taking Protiumi.v. just because you feel better. If you stop taking your injections too soon, your symptoms may return.

Will Protiumi.v. cause any problems?

Like all medicines, Protiumi.v. can cause side effects, although not everybody gets them.

Common side effects (affect less than 1 in 10 people) are:

• Headache


• Stomach pain


• Constipation


• Wind


• Diarrhoea.

Uncommon side effects (affect less than 1 in 100 people) are:

• Skin rash


• Itchiness


• Feeling sick


• Being sick


• Dizziness


• Blurred vision.

Rare side effects (affect less than 1 in 1000 people) are:

• Dry mouth


• Joint pain


• Depression


• Hallucination


• Disorientation


• Confusion.

Very rare side effects (affect less than 1 in 10,000 people) are:

• A reduction in white cells in your blood (often seen by increased infections)


• A reduction in platelets in your blood (often seen as a tendency to bruise or bleed)


• Swollen ankles, legs or arms


• Severe anaphylactic reactions (sometimes seen as swollen tongue or throat, feeling faint, increased sweating or increased pulse rate)


• Fever


• Muscle pain


• Swelling of your kidneys (sometimes seen as lower back discomfort, changes (either more
  or less) in the amount of urine you pass or traces of blood in your urine)


• Sensitivity to sunlight


• Blistering of the skin


• Increases in some of the chemicals in your liver


• Increased fats in your blood


• Liver problems (often seen as yellowing of the skins or the whites of your eyes).

If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, tell your doctor or pharmacist.

Storing your medicine

Keep your medicine out of the reach and sight of children.

Do not take your medicine after the expiry date given on the carton. The expiry date is the last day of the month shown on the pack.

Do not store above 25°C. Keep the container in the outer carton.

Once Protiumi.v. has been prepared as a solution ready for injection, it is usually used immediately and should not be kept for more than 12 hours, at no more than 25°C.

Do not use Protiumi.v. if you notice the prepared solution is cloudy or contains particles.

The contents of a container should only be used once and any leftover medicine disposed
of. Give any leftover medicine to your doctor or nurse. If you do this, it will help protect the
environment. Do not put your medicine down the drain or in the dustbin.

Protiumi.v. is a registered trademark of Nycomed GmbH Germany.

This leaflet was last approved in January 2008.

GRBR F.1/0108/3.5594.92

Tandem Capsules

Generic Name: ferrous fumarate and ferrous asparto glycinate

Dosage Form: capsule
see all prescribing information for Tandem DESCRIPTION: Each capsule contains: Ferrous Fumarate (anhydrous) .191.1 mg Polysaccharide Iron Complex..135.9 mg (Equivalent to about 125 mg of elemental iron) Vitamin C (from ProAscorb C‡).40 mg Vitamin B3 (from ProAscorb C‡) ..3 mg  Inactive Ingredients: Hypromellose, Magnesium Stearate, Titanium Dioxide,

CLINICAL PHARMACOLOGY: IntegraTM is unique in that it utilizes two (2) different forms of iron, i.e., Ferrous Fumarate and Polysaccharide Iron Complex (as cell-contracted akaganèite), making available a total of 125 mg of elemental iron per capsule as follows:

Ferrous Fumarate (anhydrous)    191.1 mg Polysaccharide iron complex (PIC)    135.9 mg

Ferrous Fumarate: Provides about 62.5 mg of elemental iron per dose. Ferrous Fumarate is an anhydrous salt of a combination of ferrous iron and fumaric acid, containing 33% of iron per weight. The acute toxicity in experimental animals is low and Ferrous Fumarate is well tolerated clinically. As a ferrous salt, it is more efficiently absorbed in the duodenum. Iron absorption is maximal in the duodenum unlike Ferrous Sulfate, which must be protected against oxidation through coating. The IntegraTM Capsule is superior to enteric coated or sustained release preparations that are apt to pass beyond the duodenum and would therefore be poorly absorbed. Ferrous Fumarate contrasts very favorably with the availability of the 20% of elemental iron of ferrous sulfate, and the 13% of elemental iron of ferrous gluconate. Calculation of Dose should be in terms of elemental iron and three doses ranging from 50-100 mg of elemental iron is usually adequate.

Polysaccharide Iron Complex: Provides about 62.5 mg elemental iron, as a cell-contracted akaganèite. It is a product of ferric iron complexed to a low molecular weight polysaccharide. This polysaccharide is produced by the extensive hydrolysis of starch and is a dark brown powder, that dissolves in water to form a very dark brown solution, which is virtually odorless and tasteless.

All IntegraTM products include a unique patented source of iron, e.g. Ferrous Fumarate and Polysaccharide Iron Complex (U.S. Patent No: 11/243,043 Pending). "An increase in tolerability is observed with the (patented formulation) and is believed to occur as the result of distributing the total iron content in the composition among compounds that provide iron to the patient's blood stream via two different mechanisms. The ferrous salts are readily absorbed in the upper gut, by direct dissolution and absorption of the ferrous iron by the bloodstream. However, the iron available from PIC is absorbed in the lower gut, via an active protein transport mechanism".

Clinical Studies: Because Ferrous Fumarate is an organic complex, it contains no free ions, either ferric or ferrous. Polysaccharide Iron Complex is clinically non-toxic. Prior studies in rats demonstrated that Polysaccharide Iron Complex (PIC), when administered as a single oral dose to Sprague Dawley rats, did not produce evidence of toxicity at a dosage level of 5000 mg Iron/kg: (An Acute Oral Toxicity Study in Rats with Polysaccharide-Iron Complex. T.N.Merriman, M. Aikman and R.E. Rush, Springborn Laboratories. Inc. Spencerville, Ohio Study No. 3340.1 March - April 1994). Other clinical studies had demonstrated that Poly-saccharide Iron gives a good hematopoietic response with an almost complete absence of the side effects usually associated with oral iron therapy. Picinni and Ricciotti suggested in 1982, that "the therapeutic effectiveness of Polysaccharide Iron Complex when compared with iron fumarate in the treatment of iron deficiency anemia, appears to be as active as the iron fumarate and as well tolerated, however, it exerted a greater influence on the level of hemoglobin and on the number of red cells..." and that, "it has been exceptionally well tolerated by all patients" (Picinni, L.-Ricciotti, M. 1982. Therapeutic effectiveness of an iron-polysaccharide complex in comparison with iron fumarate in the treatment of iron deficiency anemias): PANMINERVA MEDICA-EUROPA MEDICA, Vol. 24, No. 3, pp. 213-220 (July-September 1982). The patented source of iron used in IntegraTM (Ferrous Fumarate and Polysaccharide Iron Complex) provides a high level of elemental iron with a low incidence of gastric distress.

CONCLUSION: Based on the results of this study, the oral combination of Ferrous Fumarate and Polysaccharide Iron Complex was better tolerated and safer than the oral administration of Ferrous Fumarate alone. The conclusion of this research stated, that the addition of PIC to Ferrous Fumarate surprisingly allows the same concentration of Ferrous Fumarate to be better tolerated than the Ferrous Fumarate alone.

INDICATIONS: The treatment of iron deficiency anemia, which may occur due to an increased need for iron, a deficient intake of iron, or an excessive loss of iron.

CONTRAINDICATIONS: All iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis and hemolytic anemias.

WARNING: Accidental overdose is the leading cause of fatal poisoning in children under six. Keep this and all drugs out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

PRECAUTIONS: Existing gastrointestinal diseases, i.e. peptic ulcers, regional enteritis, ulcerative colitis may be aggravated by causing the iron not to be absorbed and therefore, be ineffective in patients with steatorrhea or those with a partial gastrectomy. It is important to determine and treat the underlying cause of the anemia, in addition to the administration of IntegraTM. Indefinite administration of iron should be avoided.

DOSAGE AND ADMINISTRATION: Adults (persons over 12 years of age), One (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.

TIME AND DURATION: The hematologic response to orally administered iron is indicated by reticulocytosis of 2% to 10% depending on the severity of the anemia, beginning five to ten days after initiation of therapy. A rise in hemoglobin value is observable at the end of the second week. When therapy is adequate, hemoglobin value increases 0.1 to 0.2 gm per 100 ml of blood a day and usually becomes normal in two months. However, to improve body iron stores, treatment may be continued from 3 to 12 months, after the hemoglobin has returned to normal. If no satisfactory response is noted after three weeks of therapy, consideration should be given to (1) whether dosage recommendations have been followed, (2) blood loss is occurring simultaneously, (3) whether there are complicating causes, such as infection, defects in absorption or utilization, (4) whether diagnosis or iron-deficiency was correct.

WARNING: Do not administer to pediatric patients. Do not exceed recommended dosage. Keep this and all drugs out of reach of pediatric patients. If you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

TANDEM   ferrous fumarate and polysacchride iron complex   capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52747-900 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS FUMARATE (IRON) FERROUS FUMARATE 162 mg FERROUS ASPARTO GLYCINATE (IRON) FERROUS ASPARTO GLYCINATE 115.2 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color brown (Light creamy brown) Score score with uneven pieces Shape CAPSULE (Tandem) Size 18mm Flavor Imprint Code Tandem;US Contains

Packaging # NDC Package Description Multilevel Packaging 1 52747-900-90 90 CAPSULE In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/17/2006

TANDEM - F   ferrous fumarate and polysacchride iron complex and folic acid  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52747-901 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS ASPARTO GLYCINATE (IRON) FERROUS ASPARTO GLYCINATE 115.2 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg FERROUS FUMARATE (IRON) FERROUS FUMARATE 162 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color red (red) , brown (brown) Score score with uneven pieces Shape CAPSULE Size 18mm Flavor Imprint Code Tandem;F;US Contains

Packaging # NDC Package Description Multilevel Packaging 1 52747-901-60 90 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/17/2006

TANDEM PLUS   ferrous fumarate and polysacchride iron vitamin mineral complex supplement  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52747-902 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS FUMARATE (IRON) FERROUS FUMARATE 162 mg FERROUS ASPARTO GLYCINATE (IRON) FERROUS ASPARTO GLYCINATE 115.2 mg SODIUM ASCORBATE (ASCORBIC ACID) ASCORBIC ACID 200 mg THIAMINE MONONITRATE (THIAMINE) THIAMINE 10 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 6 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 5 mg CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 15 ug NIACINAMIDE (NIACIN) NIACIN 30 mg CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 10 mg ZINC SULFATE (ZINC CATION) ZINC CATION 18.2 mg MAGNESIUM SULFATE (MAGNESIUM) MAGNESIUM 1.3 mg CUPRIC SULFATE (COPPER) COPPER 0.8 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color pink (Pink) Score score with uneven pieces Shape CAPSULE Size 22mm Flavor Imprint Code Tandem;Plus;US Contains

Packaging # NDC Package Description Multilevel Packaging 1 52747-902-60 90 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/17/2006

Labeler - US Pharmaceutical Corporation (048318224)

Registrant - US Pharmaceutical Corporation (048318224)

Revised: 12/2009US Pharmaceutical Corporation

More Tandem Capsules resources

• Tandem Capsules Use in Pregnancy & Breastfeeding
• Tandem Capsules Drug Interactions
• Tandem Capsules Support Group
• 1 Review for Tandem - Add your own review/rating

Compare Tandem Capsules with other medications

• Iron Deficiency Anemia

Truvada

Pronunciation: EM-trye-SYE-ta-been/ten-OF-oh-vir
Generic Name: Emtricitabine/Tenofovir
Brand Name: Truvada

Severe and sometimes fatal lactic acidosis (a buildup of lactic acid in the blood) and liver problems have occurred with this type of medicine. The risk may be greater in women, patients who are very overweight, or patients who have been taking nucleoside medicines (eg, emtricitabine, tenofovir) for a long time.

Tell your doctor right away if you develop symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or light-headedness; fast or irregular heartbeat). Tell your doctor right away if you develop symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent loss of appetite, nausea, stomach pain).

Truvada has not been approved to treat hepatitis B virus (HBV) infection. The safety and effectiveness of Truvada in patients who have both HBV and HIV infection have not been confirmed. Some patients with both HBV and HIV infection who took Truvada experienced severe worsening of HBV infection after they stopped taking it. Patients who have both HBV and HIV infection need close medical follow-up to check for worsening liver problems for at least several months after they stop Truvada. Keep all doctor and lab appointments. Do not stop taking Truvada without checking with your doctor.

Truvada is used for:

Treating HIV infection in combination with other medicines. Truvada is not a cure for HIV or AIDS. It may also be used for other conditions as determined by your doctor.

Truvada is an antiviral combination of 2 reverse transcriptase inhibitors. It works by reducing the amount of HIV in the body by blocking its ability to multiply.

Do NOT use Truvada if:

• you are allergic to any ingredient in Truvada


• you have severe kidney problems or if you require dialysis treatments


• you are taking adefovir, medicines that contain lamivudine, or another medicine that contains emtricitabine or tenofovir


• you take a medicine that may harm your kidneys (eg, an aminoglycoside antibiotic [eg, gentamicin], amphotericin B, cyclosporine, a nonsteroidal anti-inflammatory drug [NSAID] [eg, ibuprofen], tacrolimus, vancomycin). Ask you doctor if you are not sure if any of your medicines might harm your kidneys

Contact your doctor or health care provider right away if any of these apply to you.

Before using Truvada:

Some medical conditions may interact with Truvada. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have kidney problems, lactic acidosis, abnormal liver function tests or liver problems, including HBV infection


• if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition), or if you have a history of bone problems (eg, fracture)

Some MEDICINES MAY INTERACT with Truvada. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, or medicines that may harm your kidneys (eg, an aminoglycoside antibiotic [eg, gentamicin], amphotericin B, cyclosporine, an NSAID eg, [ibuprofen], tacrolimus, vancomycin) because they may increase the risk of Truvada's side effects. Ask your doctor or pharmacist if you are not sure if any of your medicines may affect your kidneys


• Adefovir, other medicines that contain emtricitabine or tenofovir, lamivudine, or certain protease inhibitors (eg, atazanavir, lopinavir/ritonavir, tipranavir) because they may increase the risk of Truvada's side effects


• Didanosine because the risk of its side effects may be increased by Truvada

This may not be a complete list of all interactions that may occur. Ask your health care provider if Truvada may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Truvada:

Use Truvada as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Truvada. Talk to your pharmacist if you have questions about this information.


• Take Truvada by mouth with or without food.


• Continue to take Truvada even if you feel well. Do not miss any doses.


• Do not suddenly stop taking Truvada without checking with your doctor. This may cause the virus to become less sensitive to this or other medicines. Some conditions (eg, hepatitis B) could become worse if you suddenly stop taking Truvada.


• Taking Truvada at the same time each day will help you remember to take it.


• If you miss a dose of Truvada, take it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than 1 dose in the same day.

Ask your health care provider any questions you may have about how to use Truvada.

Important safety information:

• Truvada may cause dizziness or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Truvada with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• You should be tested for HBV infection before you start to take Truvada.


• Keep a list of all the medicines that you take. Make a new list each time medicines are added or stopped. Find out about medicines that should not be taken while you are using Truvada. Be sure that each of your health care providers knows all the medicines that you are taking.


• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Truvada, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.


• Truvada is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.


• Truvada does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.


• Truvada is not for the treatment of HBV. If you have HBV and HIV, you will need close medical follow-up for several months after stopping treatment with Truvada. Follow-up includes medical exams and blood tests to check for HBV infection that could be getting worse.


• The risk of severe side effects (eg, lactic acidosis, severe liver problems) may be greater in women, patients who are very overweight (obese), and patients who have taken nucleoside medicines (eg, emtricitabine, tenofovir) for a long time. Talk with your doctor if you have questions about your risk for severe side effects from Truvada.


• Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Truvada. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.


• Truvada may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Truvada.


• Ask your doctor if you should take a calcium and vitamin D supplement while you are taking Truvada.


• Lab tests, including liver function, kidney function, and bone mineral density, may be performed while you use Truvada. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Truvada should be used with extreme caution in CHILDREN younger than 12 years old, in children weighing less than 77 lb (35 kg), and in ELDERLY patients older than 65 years old; safety and effectiveness in these patients have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Truvada while you are pregnant. It is not known if Truvada is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Truvada to the baby. Do not breast-feed while taking Truvada.

Possible side effects of Truvada:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; back pain; cough; darkened skin color on the palms of hands or soles of feet; diarrhea; dizziness; gas; headache; indigestion; joint pain; loss of appetite; nausea; sinus drainage; skin discoloration (small spots or freckles); strange dreams; sweating; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); bone pain; chest pain; fever; mental or mood changes (eg, depression); muscle pain or weakness; numbness, burning, pain, or tingling in the hands or feet; severe or persistent dizziness; severe or persistent nausea or vomiting; shortness of breath; stomach pain; symptoms of kidney problems (eg, increased or decreased urination, increased thirst); symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or light-headedness; fast or irregular heartbeat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; persistent loss of appetite).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Truvada side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Truvada:

Store Truvada at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Do not use Truvada if the seal over the bottle opening is broken or missing. Keep Truvada in its original container and keep the container tightly closed. Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away, make sure that children or pets cannot find them. Keep Truvada out of the reach of children and away from pets.

General information:

• If you have any questions about Truvada, please talk with your doctor, pharmacist, or other health care provider.


• Truvada is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Truvada. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Truvada resources

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

• Truvada Prescribing Information (FDA)


• Truvada Advanced Consumer (Micromedex) - Includes Dosage Information


• Truvada Consumer Overview

Compare Truvada with other medications

• HIV Infection
• Nonoccupational Exposure

Twynsta

Pronunciation: TEL-mi-SAR-tan/am-LOE-di-peen
Generic Name: Telmisartan/Amlodipine
Brand Name: Twynsta

Do not use Twynsta if you are pregnant. It may cause birth defects or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away.

Twynsta is used for:

Treating high blood pressure. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Twynsta is a calcium channel blocker and angiotensin II receptor blocker combination. It works by relaxing the blood vessels.

Do NOT use Twynsta if:

• you are allergic to any ingredient in Twynsta


• you are pregnant


• you are taking ramipril

Contact your doctor or health care provider right away if any of these apply to you.

Before using Twynsta:

Some medical conditions may interact with Twynsta. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are a woman of childbearing age


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you are vomiting or have diarrhea


• if you are dehydrated, have low blood volume or low blood sodium levels, or are on a low-salt (sodium) diet


• if you have gallbladder, liver, or kidney problems; high blood potassium levels; low blood pressure; blood vessel problems; or heart problems (eg, heart failure, angina, narrowing of heart blood vessels)


• if you have a history of a stroke or a heart attack


• if you have diabetes and you are also taking aliskiren


• if you are on dialysis or will be having surgery


• if you are taking another medicine for blood pressure or heart problems

Some MEDICINES MAY INTERACT with Twynsta. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood pressure may be increased


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, celecoxib, ibuprofen) because the risk of kidney problems may be increased and they may decrease Twynsta's effectiveness


• Aliskiren, potassium-sparing diuretics (eg, triamterene), or potassium supplements because the risk of high blood potassium levels may be increased


• ACE inhibitors (eg, lisinopril, ramipril) because the risk of serious kidney problems and high blood potassium levels may be increase


• Potassium-sparing diuretics (eg, triamterene) or potassium supplements because high blood potassium levels may occur


• Certain azole antifungals (eg, itraconazole, ketoconazole), conivaptan, or HIV protease inhibitors (eg, ritonavir) because they may increase the risk of Twynsta's side effects


• Digoxin, lithium, or simvastatin because the risk of their side effects may be increased by Twynsta

This may not be a complete list of all interactions that may occur. Ask your health care provider if Twynsta may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Twynsta:

Use Twynsta as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Twynsta. Talk to your pharmacist if you have questions about this information.


• Take Twynsta by mouth with or without food.


• Do not take a tablet out of the blister until you are ready to take Twynsta.


• To remove a tablet from the blister, peel the paper layer away from the foil, then push the tablet through the foil.


• Be sure to drink enough liquids while you are taking Twynsta. If you do not, you may become dehydrated, which may increase your risk of low blood pressure. Discuss any questions or concerns with your doctor.


• Take Twynsta on a regular schedule to get the most benefit from it. Taking Twynsta at the same time each day will help you remember to take it.


• Continue to take Twynsta even if you feel well. Do not miss any doses.


• If you miss a dose of Twynsta, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Twynsta.

Important safety information:

• Twynsta may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Twynsta with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Twynsta may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• It may take up to 4 weeks to get the full benefit from Twynsta. Do not stop using Twynsta without checking with your doctor.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


• If vomiting, diarrhea, or excessive sweating occur, you will need to take care not to become dehydrated. This could increase your risk for low blood pressure. Contact your doctor for instructions.


• Tell your doctor or dentist that you take Twynsta before you receive any medical or dental care, emergency care, or surgery.


• Talk with your doctor or pharmacist about all of your blood pressure medicines and how to use them. Do not start, stop, or change the dose of any blood pressure medicine unless your doctor tells you to.


• Lab tests, including blood pressure, liver and kidney function, and blood electrolyte levels, may be performed while you use Twynsta. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Twynsta with caution in the ELDERLY; they may be more sensitive to its effects.


• Twynsta should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Twynsta may cause birth defects, or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Twynsta is found in breast milk. Do not breast-feed while taking Twynsta.

Possible side effects of Twynsta:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; flushing of the face and neck; mild back pain; nausea; stomach pain; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); change in the amount of urine produced; chest, jaw, or left arm pain; fainting; fast, slow, or irregular heartbeat; mental or mood changes (eg, depression); muscle pain, aches, or weakness; numbness of an arm or leg; severe or persistent diarrhea, nausea, or stomach pain; severe or persistent dizziness or light-headedness; shortness of breath; sudden, severe headache or vomiting; sudden, unexplained weight gain; sudden vision changes; swelling of the feet, ankles, or hands; worsening of angina pain (eg, longer, more often, more severe); yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Twynsta side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; fast or slow heartbeat; severe dizziness or light-headedness.

Proper storage of Twynsta:

Store Twynsta between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Twynsta out of the reach of children and away from pets.

General information:

• If you have any questions about Twynsta, please talk with your doctor, pharmacist, or other health care provider.


• Twynsta is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Twynsta. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Twynsta resources

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

• Twynsta Prescribing Information (FDA)


• Twynsta Advanced Consumer (Micromedex) - Includes Dosage Information


• Twynsta Consumer Overview

Compare Twynsta with other medications

• High Blood Pressure