List Article Directory New Hampshire

Wednesday, 12 September 2012

Isotrex Gel (Stiefel Laboratories (UK) Limited)

1. Name Of The Medicinal Product

Isotrex Gel

2. Qualitative And Quantitative Composition

Isotretinoin 0.05% w/w

For excipients, see 6.1.

3. Pharmaceutical Form

Gel for topical application

4. Clinical Particulars

4.1 Therapeutic Indications

Isotrex Gel is intended for use in the treatment of mild to moderate inflammatory and non-flammatory acne vulgaris.

4.2 Posology And Method Of Administration

Apply Isotrex Gel sparingly over the whole affected area once or twice daily.

Patients should be advised that 6-8 weeks of treatment may be required before a therapeutic effect is observed.

The safety and efficacy of Isotrex Gel has not been established in children since acne vulgaris rarely presents in this age group.

There are no specific recommendations for use in the elderly. Acne vulgaris does not present in the elderly.

4.3 Contraindications

Isotrex Gel should not be used in patients with known hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Contact with the mouth, eyes and mucous membranes and with abraded or eczematous skin should be avoided. Care should be taken not to let the medication accumulate in skin fold areas and in the angles of the nose.

Application to sensitive areas of skin, such as the neck, should be made with caution.

Although tretinoin has not been shown to initiate or promote carcinogenesis in humans, tretinoin applied topically to albino hairless mice had resulted in a dose-related acceleration in ultraviolet-B radiation induced cutaneous tumours. The same author also observed the opposite effect in another study of low, non-irritating concentrations of tretinoin. The significance of these findings as related to man is unknown; however, caution should be observed in patients with a personal or family history of cutaneous epithelioma. Exposure to sunlight of areas treated with Isotrex Gel should be avoided or minimised. When exposure to strong sunlight cannot be avoided a sunscreen product and protective clothing should be used. Patients with sunburn should not use Isotrex Gel due to the possibility of increased sensitivity to sunlight. The use of sunlamps should be avoided during treatment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant topical medication should be used with caution during therapy with Isotrex Gel. Particular caution should be exercised when using preparations containing a peeling agent (for example Benzoyl Peroxide) or abrasive cleansers.

4.6 Pregnancy And Lactation

Category B1.

There is inadequate evidence of the safety of topically applied isotretinoin in human pregnancy.

Isotretinoin has been associated with teratogenicity in humans when administered systemically. Reproduction studies conducted in rabbits using Isotrex Gel applied topically at up to 60 times the human dose have, however, revealed no harm to the foetus. The use of Isotrex gel should be avoided during pregnancy.

Use during lactation

Percutaneous absorption of isotretinoin from Isotrex Gel is negligible. It is not known, however, whether isotretinoin is excreted in human milk. Isotrex Gel should not be used during lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable; the product is a topical preparation which acts locally at the site of application.

4.8 Undesirable Effects

In normal use, Isotrex Gel may cause stinging, burning or irritation; erythema and peeling at the site of application may occur.

If undue irritation occurs, treatment should be interrupted temporarily and resumed once the reaction subsides. If irritation persists, treatment should be discontinued. Reactions will normally resolve on discontinuation of therapy.

4.9 Overdose

Acute overdosage of Isotrex Gel has not been reported to date. Accidental ingestion of Isotrex Gel resulting in overdosage of isotretinoin could be expected to induce symptoms of hypervitaminosis A. These include severe headaches, nausea or vomiting, drowsiness, irritability and pruritus.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Isotretinoin is structurally and pharmacologically related to Vitamin A which regulates epithelial cell growth and differentiation.

The pharmacological action of isotretinoin remains to be fully elucidated. When used systemically it suppresses sebaceous gland activity and reduces sebum production; it also affects comedogenesis, suppresses Propionibacterium acnes and reduces inflammation.

When applied topically, the mode of action of isotretinoin may be comparable with its stereoisomer, tretinoin. Tretinoin stimulates mitosis in the epidermis and reduces intercellular cohesion in the stratum corneum; it contests the hyperkeratosis characteristic of acne vulgaris and aids desquamation, preventing the formation of lesions. Tretinoin also mediates an increased production of less cohesive epidermal sebaceous cells, this appears to promote the initial expulsion and subsequent prevention of comedones.

5.2 Pharmacokinetic Properties

Percutaneous absorption of isotretinoin from the gel is negligible. After applying 30g per day of isotretinoin 0.05% gel to acne of the face, chest and back for 30 days, HPLC assays for isotretinoin and tretinoin demonstrated non-detectable levels in the plasma samples (0.02μg/ml). Applying ¹⁴C isotretinoin in a cream base on the healthy skin of human volunteers resulted in only 0.03% of the topically applied dose being recovered through estimating the radioactivity of blood, urine and faecal samples

5.3 Preclinical Safety Data

Not applicable. The relevant information is given in Section 4.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Butylated Hydroxytoluene

Hydroxypropylcellulose

Ethanol

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

a) For the product as packaged for sale

3 years

b) After first opening the container

Two months

6.4 Special Precautions For Storage

Store below 25°C

6.5 Nature And Contents Of Container

Aluminium tube of 5g, 15g, 25g, 30g, 50g, 60g fitted with a screw cap.

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for use or handling of Isotrex Gel.

7. Marketing Authorisation Holder

GlaxoSmithKline UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as Stiefel

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

8. Marketing Authorisation Number(S)

PL 19494/0063

9. Date Of First Authorisation/Renewal Of The Authorisation

20/12/2005

10. Date Of Revision Of The Text

14 December 2010

Telavancin

Pronunciation: TEL-a-VAN-sin
Generic Name: Telavancin
Brand Name: Vibativ

Pregnant women should usually not use Telavancin. Women who may become pregnant must have a negative pregnancy test before starting Telavancin. They must also use effective birth control while they use Telavancin. Talk with your doctor for more information.

Telavancin is used for:

Treating serious skin infections caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Telavancin is an antibiotic. It works by killing sensitive bacteria.

Do NOT use Telavancin if:

you are allergic to any ingredient in Telavancin

you have certain heart problems (eg, congenital long QT syndrome, QT interval prolongation, heart failure, severe left ventricular hypertrophy)

you are pregnant

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

Before using Telavancin:

Some medical conditions may interact with Telavancin. 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 diarrhea, bloody stools, stomach cramps, or a fever

if you have a history of high blood pressure, kidney problems, diabetes, heart disease or heart problems, or a family history of certain heart problems (eg, prolonged QT interval)

if you are taking a blood thinner or medicine to control your heart rate or rhythm (eg, antiarrhythmics)

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

Certain blood pressure medicines (eg, angiotensin-converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs]), diuretics (eg, furosemide), or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, aspirin) because the risk of kidney problems may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Telavancin 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 Telavancin:

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

Telavancin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Telavancin refilled.

Telavancin is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Telavancin at home, a health care provider will teach you how to use it. Be sure you understand how to use Telavancin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

To clear up your infection completely, use Telavancin for the full course of treatment. Keep using it even if you feel better in a few days.

Continue to use Telavancin even if you feel well. Do not miss any doses.

Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

If you miss a dose of Telavancin, contact your doctor right away.

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

Important safety information:

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

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

Be sure to use Telavancin 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 Telavancin 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.

Telavancin may interfere with certain lab tests, including coagulation tests and urine protein tests. Be sure your doctor and lab personnel know you are using Telavancin.

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

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

Telavancin should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: Telavancin may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Telavancin is found in breast milk. If you are or will be breast-feeding while you use Telavancin, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Telavancin:

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; foamy urine; headache; loss of appetite; metallic or soapy taste in the mouth; mild diarrhea; mild pain or redness at the injection site; nausea; taste changes; 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 or watery stools; fainting; fast or irregular heart beat; fever; flushing of the skin; severe or persistent diarrhea; stomach cramps.

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: Telavancin 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 ( http://www.aapcc.org), or emergency room immediately.

Proper storage of Telavancin:

Telavancin is usually handled and stored by a health care provider. If you are using Telavancin at home, store Telavancin as directed by your pharmacist or health care provider.

General information:

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

Telavancin 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 Telavancin. 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

More Telavancin resources

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

Telavancin Professional Patient Advice (Wolters Kluwer)

telavancin Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

Telavancin Hydrochloride Monograph (AHFS DI)

Vibativ Prescribing Information (FDA)

Vibativ Consumer Overview

Compare Telavancin with other medications

Skin and Structure Infection

Sunday, 9 September 2012

C1 Esterase Inhibitor (Human)

Pronunciation: C1 ES-ter-ase in-HIB-i-ter
Generic Name: C1 Esterase Inhibitor (Human)
Brand Name: Cinryze

C1 Esterase Inhibitor (Human) is used for:

Preventing angioedema attacks in teenagers and adults with hereditary angioedema (HAE).

C1 Esterase Inhibitor (Human) is a C1 esterase inhibitor (human). It works by helping to control inflammation and parts of the immune system. This helps to prevent the swelling and/or painful attacks that occur with HAE.

Do NOT use C1 Esterase Inhibitor (Human) if:

you are allergic to any ingredient in C1 Esterase Inhibitor (Human)

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

Before using C1 Esterase Inhibitor (Human):

Some medical conditions may interact with C1 Esterase Inhibitor (Human). 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 blood clotting problems, such as blood clots in your veins or lungs (eg, deep vein thrombosis, pulmonary embolism)

Some MEDICINES MAY INTERACT with C1 Esterase Inhibitor (Human). However, no specific interactions with C1 Esterase Inhibitor (Human) are known at this time.

Ask your health care provider if C1 Esterase Inhibitor (Human) 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 C1 Esterase Inhibitor (Human):

Use C1 Esterase Inhibitor (Human) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with C1 Esterase Inhibitor (Human). Talk to your pharmacist if you have questions about this information.

C1 Esterase Inhibitor (Human) may be given as an injection at your doctor's office, hospital, or clinic. If you will be using C1 Esterase Inhibitor (Human) at home, a health care provider will teach you how to use it. Be sure you understand how to use C1 Esterase Inhibitor (Human). Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

After mixing, C1 Esterase Inhibitor (Human) should be colorless to slightly blue. Do not use C1 Esterase Inhibitor (Human) if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

C1 Esterase Inhibitor (Human) must be mixed before use. Use within 3 hours after mixing.

Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

If you miss a dose of C1 Esterase Inhibitor (Human), contact your doctor right away.

Ask your health care provider any questions you may have about how to use C1 Esterase Inhibitor (Human).

Important safety information:

C1 Esterase Inhibitor (Human) may contain albumin, which comes from human blood. There is a very rare risk of getting a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease from products with albumin. No cases of these problems have been found in patients who have used C1 Esterase Inhibitor (Human).

The risk of blood clots (eg, in your veins or lungs) may be increased with high doses of C1 Esterase Inhibitor (Human). Tell your doctor if you have a history of blood clotting problems. Contact your doctor right away if you develop symptoms of a blood clot (eg, changes in consciousness, speech, or vision; one-sided weakness or loss of muscle control; severe or persistent headache; chest pain; shortness of breath; pain, numbness, or swelling in your arms or legs) while you are using C1 Esterase Inhibitor (Human). Talk with your doctor for more information.

C1 Esterase Inhibitor (Human) should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: It is not known if C1 Esterase Inhibitor (Human) can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using C1 Esterase Inhibitor (Human) while you are pregnant. It is not known if C1 Esterase Inhibitor (Human) is found in breast milk. If you are or will be breast-feeding while you use C1 Esterase Inhibitor (Human), check with your doctor. Discuss any possible risks to your baby.

Possible side effects of C1 Esterase Inhibitor (Human):

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:

Headache; stuffy or runny nose.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or shortness of breath; tightness in the chest; fast heartbeat; severe dizziness or lightheadedness; fainting; swelling of the mouth, face, lips, or tongue; blue lips or gums; wheezing); symptoms of infection (eg, fever, sore throat, cough).

See also: C1 Esterase Inhibitor (Human) 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 changes in consciousness, speech, or vision; chest pain; one-sided weakness or loss of muscle control; pain, numbness, or swelling in your arms or legs; severe or persistent headache; shortness of breath.

Proper storage of C1 Esterase Inhibitor (Human):

Store C1 Esterase Inhibitor (Human) in the refrigerator or at room temperature, between 36 and 77 degrees F (2 and 25 degrees C). Do not freeze. Store in original packaging until just before use. Do not use C1 Esterase Inhibitor (Human) if the expiration date has passed. After mixing, you may store C1 Esterase Inhibitor (Human) at room temperature for up to 3 hours. If you do not use it within 3 hours after mixing, throw it away. Keep C1 Esterase Inhibitor (Human) out of the reach of children and away from pets.

General information:

If you have any questions about C1 Esterase Inhibitor (Human), please talk with your doctor, pharmacist, or other health care provider.

C1 Esterase Inhibitor (Human) 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 C1 Esterase Inhibitor (Human). 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

More C1 Esterase Inhibitor (Human) resources

C1 Esterase Inhibitor (Human) Side Effects (in more detail)
C1 Esterase Inhibitor (Human) Use in Pregnancy & Breastfeeding
C1 Esterase Inhibitor (Human) Support Group
3 Reviews for C1 Esterase Inhibitor (Human) - Add your own review/rating

Compare C1 Esterase Inhibitor (Human) with other medications

Hereditary Angioedema

Saturday, 8 September 2012

Skin Infection Medications

Drugs associated with Skin Infection

The following drugs and medications are in some way related to, or used in the treatment of Skin Infection. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Skin Infection

Secondary Cutaneous Bacterial Infections (11 drugs)

Toxic Epidermal Necrolysis (17 drugs)

Learn more about Skin Infection

Medical Encyclopedia:

Carbuncle

Drug List:

Augmentin-Es-600-Suspension

Augmentin-Xr-Extended-Release-Tablets

Avelox

Avelox-I-V

Azactam

Azithromycin-3-Day-Dose-Pack

Bactocill

Beepen-Vk

Biaxin

Biaxin-Xl-Extended-Release-Tablets

Bicillin-C-R

Bicillin-C-R-900-300

Bicillin-L-A-Suspension

Cipro-Xr-Extended-Release-Tablets

Claforan

Cleocin

Cleocin-Hcl

Cleocin-Pediatric-Suspension

Cleocin-Phosphate-Iv

Cubicin

Dispermox

Doryx-Delayed-Release-Capsules

E-E-S-Granules-Suspension

Eryc-Delayed-Release-Particles-Capsules

Eryped-Drops

Erythrocin

Erythromycin-Lactobionate-I-V

Erythrocin-Stearate-Filmtab

Ocudox-Convenience-Kit

Penicillin-G-Procaine-Injectable-Suspension

Vancocin-Hcl-Pulvules

Zmax-Extended-Release-Oral-Suspension

Zosyn

Thursday, 6 September 2012

Terbinafine Gel

Pronunciation: TER-bin-a-feen
Generic Name: Terbinafine
Brand Name: Lamisil AT

Terbinafine Gel is used for:

Relieving itching, burning, cracking, and scaling associated with jock itch, athlete's foot, ringworm, and other fungal infections of the skin.

Terbinafine Gel is topical antifungal agent. It works by killing sensitive fungi.

Do NOT use Terbinafine Gel if:

you are allergic to any ingredient in Terbinafine Gel

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

Before using Terbinafine Gel:

Some medical conditions may interact with Terbinafine Gel. 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

Some MEDICINES MAY INTERACT with Terbinafine Gel. Because little, if any, of Terbinafine Gel is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Terbinafine Gel 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 Terbinafine Gel:

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

Wash the affected area with soap and water. Be sure the area is completely dry before applying Terbinafine Gel.

Apply a thin layer of medicine and rub in gently as directed by your doctor or the package labeling.

If you are using Terbinafine Gel for athlete's foot, make sure you apply the medicine to the spaces between the toes. Wear well-fitting, ventilated shoes. Change shoes and socks at least once a day.

Wash your hands immediately after using Terbinafine Gel unless your hands are part of the treated area.

To clear up your infection completely, use Terbinafine Gel for the full course of treatment. Keep using it even if you notice improvement in a few days.

If you miss a dose of Terbinafine Gel, use 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 use 2 doses at once.

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

Important safety information:

Terbinafine Gel is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with cool water.

Do not use Terbinafine Gel on the nails or scalp. Do not use it for vaginal yeast infections.

Do not use more than the recommended dose or use for longer than prescribed without checking with your doctor.

Terbinafine Gel should not be used in CHILDREN younger than 12 years old without first checking with your child's doctor; safety and effectiveness in these children 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 Terbinafine Gel while you are pregnant. It is not known if Terbinafine Gel is found in breast milk after topical use. If you are or will be breast-feeding while you use Terbinafine Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Terbinafine Gel:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with this product. 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); new or worsening skin irritation.

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 Terbinafine Gel:

Store Terbinafine Gel at or below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Keep Terbinafine Gel out of the reach of children and away from pets.

General information:

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

Terbinafine Gel 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 Terbinafine Gel. 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

More Terbinafine resources

Terbinafine Use in Pregnancy & Breastfeeding
Terbinafine Support Group
5 Reviews for Terbinafine - Add your own review/rating

Compare Terbinafine with other medications

Tinea Corporis
Tinea Cruris
Tinea Pedis
Tinea Versicolor

Monday, 3 September 2012

Acetaminophen Tablet

Dosage Form: tablet

OTC - ACTIVE INGREDIENT

ACTIVE INGREDIENT

(in each tablet)

Acetaminophen 325 mg

PURPOSES

Pain Reliever/Fever Reducer

USES

for the temporary relief of minor aches and pains due to:

●: Headache

●: Muscular aches

●: Backache

●: Minor pain of arthritis

●: The common cold

●: Toothache

●: Premenstrual and menstrual cramps

●: Temporarily reduces fever.

Warnings

WARNINGS

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if

●: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount

●: child takes more than 5 doses in 24 hours

●: taken with other drugs containing acetaminophen

●: adult has 3 or more alcoholic drinks every day while using this product

●: Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

●: if you are allergic to acetaminophen or any of the inactive ingredients in this product

●: Ask a doctor before use if the user has liver disease.

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.

Stop use and ask a doctor if

Pain gets worse or lasts more than 10 days in adults and children

●: Pain gets worse or lasts more than 5 days in children under 12 years

●: Fever gets worse or lasts more than 3 days

●: New symptoms occur

●: Redness or swelling is present

●: These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdosage

Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DIRECTIONS

Do not take more than directed

Adults and Children 12 years and over:

-Take 2 tablets every 4 to 6 hours while symptoms last

-Do not take more than 12 tablets in 24 hours

Children 6 -11 years:

-Take 1 tablet every 4 to 6 hours while symptoms last

-Do not take more than 5 tablets in 24 hours

Children under 6 years:

acetaminophen and may cause liver damage.

OTHER INFORMATION

●: Store at room temperature 15(59

●: Use by expiration date on package.

●

INACTIVE INGREDIENT

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions? To report a Serious Adverse Event contact 1-877-835-5472.

*This product is not manufactured or distributed by McNeil Consumer Products Co., owners of the registered trademark Tylenol

INACTIVE INGREDIENT

POVIDONE

STARCH, CORN

SODIUM STARCH GLYCOLATE TYPE A POTATO

STEARIC ACID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Acetaminophen

GENERIC: Acetaminophen

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 24236-641-02

STRENGTH:325 mg

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 5 mm

IMPRINT: 30

QTY: 30

ACETAMINOPHEN
acetaminophen tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	24236-641 (16103-0353)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	white	Score	no score
Shape	ROUND (TABLET)	Size	5mm
Flavor		Imprint Code	PH020
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	24236-641-02	30 TABLET In 1 BLISTER PACK	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075659	03/09/2011

Labeler - REMEDYREPACK INC. (829572556)

Revised: 03/2011REMEDYREPACK INC.

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Saturday, 1 September 2012

hydralazine and hydrochlorothiazide

hye-DRAL-a-zeen hye-droe-KLOR-ide, hye-droe-klor-oh-THYE-a-zide

Oral route(Capsule)

This fixed-combination drug is not indicated for initial therapy of hypertension. Hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. The treatment of hypertension is not static but must be reevaluated as conditions in each patient warrant .

Commonly used brand name(s)

In the U.S.

Apresazide

Available Dosage Forms:

Capsule

Tablet

Therapeutic Class: Vasodilator/Thiazide Combination

Pharmacologic Class: Diuretic

Chemical Class: Thiazide

Uses For hydralazine and hydrochlorothiazide

Hydralazine and hydrochlorothiazide combination is used to treat high blood pressure (hypertension).

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure also may increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Hydralazine works by relaxing blood vessels and increasing the supply of blood and oxygen to the heart while reducing its workload. The hydrochlorothiazide is a type of medicine known as a thiazide diuretic and helps reduce the amount of water in the body by acting on the kidneys to increase the flow of urine.

hydralazine and hydrochlorothiazide is available only with your doctor's prescription.

Before Using hydralazine and hydrochlorothiazide

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 hydralazine and hydrochlorothiazide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to hydralazine and hydrochlorothiazide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of hydralazine and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established .

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of hydralazine and hydrochlorothiazide combination in the elderly with use in other age groups, hydralazine and hydrochlorothiazide is not expected to cause different side effects or problems in older people than it does in younger adults. However, dizziness or lightheadedness or symptoms of too much potassium loss may be more likely to occur in the elderly, who are usually more sensitive to the effects of hydralazine and hydrochlorothiazide. Also, hydralazine and hydrochlorothiazide may reduce tolerance to cold temperatures in elderly patients.

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 hydralazine and hydrochlorothiazide, 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 hydralazine and hydrochlorothiazide 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.

Dofetilide

Using hydralazine and hydrochlorothiazide 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.

Acetyldigoxin

Arsenic Trioxide

Deslanoside

Digitalis

Digitoxin

Digoxin

Droperidol

Flecainide

Ketanserin

Levomethadyl

Lithium

Metildigoxin

Ouabain

Proscillaridin

Sotalol

Using hydralazine and hydrochlorothiazide 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.

Alacepril

Apazone

Aspirin

Benazepril

Bepridil

Bromfenac

Captopril

Carbamazepine

Celecoxib

Chlorpropamide

Cholestyramine

Cilazapril

Cyclophosphamide

Delapril

Diclofenac

Diflunisal

Enalaprilat

Enalapril Maleate

Etodolac

Fenoprofen

Flurbiprofen

Fosinopril

Ginkgo

Glipizide

Gossypol

Ibuprofen

Ibuprofen Lysine

Imidapril

Indomethacin

Ketoprofen

Ketorolac

Licorice

Lisinopril

Magnesium Salicylate

Meclofenamate

Mefenamic Acid

Meloxicam

Metoprolol

Moexipril

Nabumetone

Naproxen

Nepafenac

Oxaprozin

Pentopril

Perindopril

Piroxicam

Quinapril

Ramipril

Salicylic Acid

Salsalate

Spirapril

Sulindac

Temocapril

Tolmetin

Topiramate

Trandolapril

Zofenopril

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using hydralazine and hydrochlorothiazide with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use hydralazine and hydrochlorothiazide, or give you special instructions about the use of food, alcohol, or tobacco.

Enteral Nutrition

food

Proper Use of hydralazine and hydrochlorothiazide

hydralazine and hydrochlorothiazide may cause you to have an unusual feeling of tiredness when you begin to take it. You may also notice an increase in the amount of urine or in your frequency of urination. After taking the medicine for a while, these effects should lessen. To keep the increase in urine from affecting your sleep:

If you are to take a single dose a day, take it in the morning after breakfast.

If you are to take more than one dose a day, take the last dose no later than 6 p.m., unless otherwise directed by your doctor.

However, it is best to plan your dose or doses according to a schedule that will least affect your personal activities and sleep. Ask your health care professional to help you plan the best time to take hydralazine and hydrochlorothiazide.

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

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

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

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

Dosing

The dose of hydralazine and hydrochlorothiazide 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 hydralazine and hydrochlorothiazide. 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):
- For high blood pressure:
  - Adults—1 capsule two times a day.
  - Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of hydralazine and hydrochlorothiazide, 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 hydralazine and hydrochlorothiazide

It is important that your doctor check your progress at regular visits to make sure that hydralazine and hydrochlorothiazide is working properly. Blood tests may be needed to check for unwanted effects .

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

hydralazine and hydrochlorothiazide may cause some people to have headaches or to feel dizzy. Make sure you know how you react to hydralazine and hydrochlorothiazide before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. This is more likely to occur in the morning. Getting up slowly may help. When you get up from lying down, sit on the edge of the bed with your feet dangling for 1 or 2 minutes. Then stand up slowly. If the problem continues or gets worse, check with your doctor.

The dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for a long time, exercise, or if the weather is hot. While you are taking hydralazine and hydrochlorothiazide, be careful in the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for a long time.

hydralazine and hydrochlorothiazide may cause a loss of potassium from your body.

To help prevent this, your doctor may want you to:
- eat or drink foods that have a high potassium content (for example, orange or other citrus fruit juices), or
- take a potassium supplement, or
- take another medicine to help prevent the loss of the potassium in the first place.

It is very important to follow these directions. Also, it is important not to change your diet on your own. This is more important if you are already on a special diet (as for diabetes), or if you are taking a potassium supplement or a medicine to reduce potassium loss. Extra potassium may not be necessary and, in some cases, too much potassium could be harmful.

Check with your doctor if you become sick and have severe or continuing nausea, vomiting, or diarrhea. These problems may cause you to lose additional water and potassium.

For diabetic patients:

Thiazide diuretics may raise blood sugar levels. While you are using hydralazine and hydrochlorothiazide, be especially careful in testing for sugar in your blood or urine. If you have any questions about this, check with your doctor.

Some people who take hydralazine and hydrochlorothiazide may become more sensitive to sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause severe sunburn; skin rash, redness, itching, or discoloration; or vision changes. When you begin taking hydralazine and hydrochlorothiazide:

Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.

Wear protective clothing, including a hat and sunglasses.

Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.

Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

hydralazine and hydrochlorothiazide 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 as soon as possible if any of the following side effects occur:

Signs and symptoms of too much potassium loss

Dryness of mouth

increased thirst

irregular heartbeats

mood or mental changes

muscle cramps or pain

weak pulse

Signs and symptoms of too much sodium loss

Confusion

convulsions

decreased mental activity

irritability

muscle cramps

unusual tiredness or weakness

Less common

Blisters on skin

chest pain

general feeling of discomfort or illness or weakness

joint pain

numbness, tingling, pain, or weakness in hands or feet

skin rash or itching

sore throat and fever

swelling of the lymph glands

Rare

Lower back or side pain

severe stomach pain with nausea and vomiting

unusual bleeding or bruising

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

fast or irregular heartbeat

headache

loss of appetite

nausea or vomiting

Less common

Constipation

decreased sexual ability

dizziness or lightheadedness, especially when getting up from a lying or sitting position

increased sensitivity of skin to sunlight

redness or flushing of face

shortness of breath with exercise or work

stuffy nose

watering or irritated eyes

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: hydralazine and hydrochlorothiazide side effects (in more detail)

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More hydralazine and hydrochlorothiazide resources

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

Compare hydralazine and hydrochlorothiazide with other medications

Heart Failure
High Blood Pressure