Monday, October 3, 2016

Gentex-LQ Solution


Pronunciation: car-beta-PEN-tane/gwye-FEN-e-sin/FEN-il-EF-rin
Generic Name: Carbetapentane/Guaifenesin/Phenylephrine
Brand Name: Examples include Gentex-LQ and Levall


Gentex-LQ Solution is used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.


Gentex-LQ Solution is a decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, loosening mucus and lung secretions in the chest, and making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.


Do NOT use Gentex-LQ Solution if:


  • you are allergic to any ingredient in Gentex-LQ Solution

  • you have an overactive thyroid, uncontrolled high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)

  • you take droxidopa or have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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



Before using Gentex-LQ Solution:


Some medical conditions may interact with Gentex-LQ Solution. 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 glaucoma or increased pressure in the eye, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems (eg, pheochromocytoma), mental or mood problems (eg, depression), trouble sleeping, an overactive thyroid, seizures, or stroke

  • if you have a chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, asthma, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus

  • if you are in poor health or are very overweight

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


  • Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Gentex-LQ Solution's side effects

  • Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

  • Alpha-blockers (eg, prazosin) or bromocriptine because the risk of their side effects may be increased by Gentex-LQ Solution

  • Guanadrel, guanethidine, mecamylamine, medicines for high blood pressure, methyldopa, or reserpine because their effectiveness may be decreased by Gentex-LQ Solution

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


Use Gentex-LQ Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Gentex-LQ Solution by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Drinking extra fluids while you are taking Gentex-LQ Solution is recommended. Check with your doctor for instructions.

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

  • If you miss a dose of Gentex-LQ Solution, 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 Gentex-LQ Solution.



Important safety information:


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

  • Do not use medicines that may cause drowsiness (eg, sleep adis, muscle relaxers) while you are using Gentex-LQ Solution; it may add to their effects. Ask your pharmacist if you have questions about which medicine may cause drowsiness.

  • Do not take appetite suppressants while you are taking Gentex-LQ Solution without checking with your doctor.

  • Gentex-LQ Solution has phenylephrine, carbetapentane, and guaifenesin in it. Before you start any new medicine, check the label to see if it has phenylephrine, carbentapentane, or guaifenesin in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Do not use Gentex-LQ Solution for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

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

  • If your symptoms do not get better within 5 to 7 days or if they become worse, check with your doctor.

  • If your cough persists for more than 1 week or is accompanied by a fever, rash, headache, or sore throat, contact your health care provider. A persistent cough could be a sign of a serious condition.

  • Gentex-LQ Solution may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Gentex-LQ Solution.

  • Tell your doctor or dentist that you take Gentex-LQ Solution before you receive any medical or dental care, emergency care, or surgery.

  • Use Gentex-LQ Solution with caution in the ELDERLY; they may be more sensitive to its effects.

  • Caution is advised when using Gentex-LQ Solution in CHILDREN; 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 Gentex-LQ Solution while you are pregnant. It is not known if Gentex-LQ Solution is found in breast milk. Do not breast-feed while taking Gentex-LQ Solution.


Possible side effects of Gentex-LQ Solution:


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; excitability; headache; irritability; nausea; trouble sleeping.



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); difficulty urinating; fast, slow, or irregular heartbeat; fever; hallucinations; mental or mood changes (eg, anxiety, nervousness); paleness; seizures; severe or persistent dizziness, lightheadedness, or headache; tremor.



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: Gentex-LQ 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 bizarre behavior; blurred vision; confusion; difficulty urinating; fast or shallow breathing; hallucinations; paleness; restlessness; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; unusually fast, slow, or irregular heartbeat; vomiting.


Proper storage of Gentex-LQ Solution:

Store Gentex-LQ Solution 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 Gentex-LQ Solution out of the reach of children and away from pets.


General information:


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

  • Gentex-LQ Solution 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 Gentex-LQ Solution. 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 Gentex-LQ resources


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


Compare Gentex-LQ with other medications


  • Cough and Nasal Congestion

GG-DM SR


Generic Name: dextromethorphan and guaifenesin (DEX troe me THOR fan and gwye FEN e sin)

Brand Names: Allfen DM, Altarussin DM, Aquatab DM, Benylin Expectorant, Drituss DM, Extuss LA, Fenesin DM IR, Glycotuss-DM, Guaifen DM, Mucinex Children's Cough, Mucinex DM, MucusRelief DM, Naldecon DX Liquigel, Relacon LAX, Respa-DM, Robitussin Cough & Congestion, Tussi-Bid, Tussi-Organidin DM NR, Vicks 44E


What is GG-DM SR (dextromethorphan and guaifenesin)?

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.


Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.


The combination of dextromethorphan and guaifenesin is used to treat cough and chest congestion caused by the common cold, infections, or allergies.


Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Dextromethorphan and guaifenesin may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about GG-DM SR (dextromethorphan and guaifenesin)?


Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

What should I discuss with my healthcare provider before taking GG-DM SR (dextromethorphan and guaifenesin)?


Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have emphysema or chronic bronchitis.


FDA pregnancy category C. It is not known whether dextromethorphan and guaifenesin is harmful to an unborn baby. Before you take this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.


How should I take GG-DM SR (dextromethorphan and guaifenesin)?


Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.


Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Dextromethorphan and guaifenesin granules should be sprinkled directly onto the tongue and swallowed right away.


Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.


Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?


Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous.


What should I avoid while taking GG-DM SR (dextromethorphan and guaifenesin)?


This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.


Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. Dextromethorphan and guaifenesin are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin.

GG-DM SR (dextromethorphan and guaifenesin) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • severe dizziness, anxiety, restless feeling, or nervousness;




  • confusion, hallucinations; or




  • slow, shallow breathing.



Less serious side effects may include:



  • dizziness;




  • headache;




  • skin rash or itching; or




  • nausea, vomiting, or stomach upset.



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


What other drugs will affect GG-DM SR (dextromethorphan and guaifenesin)?


Before taking this medication, tell your doctor if you are using any of the following drugs:



  • celecoxib (Celebrex);




  • cinacalcet (Sensipar);




  • darifenacin (Enablex);




  • imatinib (Gleevec);




  • quinidine (Quinaglute, Quinidex);




  • ranolazine (Ranexa);




  • ritonavir (Norvir);




  • sibutramine (Meridia);




  • terbinafine (Lamisil);




  • medicines to treat high blood pressure; or




  • an antidepressant such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.



This list is not complete and there may be other drugs that can interact with dextromethorphan and guaifenesin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More GG-DM SR resources


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


  • Atuss-12 DX Extended-Release Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Bidex-A Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Duratuss DM 12 Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • Guaifenesin DM Elixir MedFacts Consumer Leaflet (Wolters Kluwer)

  • Humibid CS MedFacts Consumer Leaflet (Wolters Kluwer)

  • Mucinex DM Prescribing Information (FDA)

  • Mucinex DM Maximum Strength Prescribing Information (FDA)

  • Robitussin DM infant drops

  • Scot-Tussin DM Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Tussin DM Prescribing Information (FDA)



Compare GG-DM SR with other medications


  • Cough
  • Expectoration


Where can I get more information?


  • Your pharmacist can provide more information about dextromethorphan and guaifenesin.

See also: GG-DM SR side effects (in more detail)


Gentamicin Cream



Pronunciation: jen-ta-MYE-sin
Generic Name: Gentamicin
Brand Name: Gentak (for ointment). Generic only (for cream).


Gentamicin Cream is used for:

Treating skin infections caused by certain bacteria.


Gentamicin Cream is a topical antibiotic. It works by slowing the growth of, or killing, sensitive bacteria.


Do NOT use Gentamicin Cream if:


  • you are allergic to any ingredient in Gentamicin Cream

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



Before using Gentamicin Cream:


Tell your health care provider 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 reactions to other topical antibiotics

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


Ask your health care provider if Gentamicin Cream 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 Gentamicin Cream:


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


  • Wash and completely dry the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying the medicine.

  • If desired, the area can be covered with gauze.

  • If you miss a dose of Gentamicin Cream, 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 Gentamicin Cream.



Important safety information:


  • Gentamicin Cream may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Gentamicin Cream. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Do not use Gentamicin Cream for future skin problems without checking with your doctor.

  • Be sure to use Gentamicin Cream 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 Gentamicin Cream 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.

  • Gentamicin Cream is for external use only. It should not be used in the eye.

  • Gentamicin Cream may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.

  • Gentamicin Cream should be used with extreme caution in CHILDREN younger than 1 year old; 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 Gentamicin Cream while you are pregnant. It is not known if Gentamicin Cream is found in breast milk. If you are or will be breast-feeding while you use Gentamicin Cream, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Gentamicin Cream:


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:



Application-site irritation (redness and itching); skin sensitivity to sunlight.



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); delayed healing of the cornea; redness, itching or swelling of the eyelids; ulcers of the cornea.



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.



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 Gentamicin Cream:

Store Gentamicin Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Keep Gentamicin Cream out of the reach of children and away from pets.


General information:


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

  • Gentamicin Cream 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 Gentamicin Cream. 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 Gentamicin resources


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


Compare Gentamicin with other medications


  • Skin and Structure Infection

Gesticare DHA



prenatal multi-vitamin/mineral

Dosage Form: delayed-release tablet
Gesticare® DHA

Delayed-Release Prenatal Multi-vitamin/Mineral Tablets with DHA and Choline

Gesticare DHA Description


Gesticare® DHA includes a light pink coated oblong-shaped tablet with “P-114” debossed on one side of the tablet and a natural DHA softgel capsule containing a pale orange oil. This novel, delayed-release formulation has been designed to avoid interference of calcium and iron absorption by releasing these minerals at different sites within the gastro-intestinal tract. Iron is released in the stomach, while calcium is released after the tablet reaches the small intestine.



Each tablet contains:

































IngredientDose
Vitamin B1 (Thiamin Mononitrate)3 mg
Vitamin B2 (Riboflavin Universal)3 mg
Vitamin B6 (Pyridoxine HCl)50 mg
Vitamin B12 (Cyanocobalamin)8 Âµg
Vitamin C (Ascorbic acid)120 mg
Niacin (Niacinamide)20 mg
Folic acid1 mg
Iron (Ferrous Fumarate)27 mg
Calcium (Calcium Carbonate)200 mg
Vitamin D (Vitamin D3)410 IU
Vitamin E (Vitamin E Acetate)30 IU
Iodine (Potassium Iodide)150 Âµg
Zinc (Zinc Oxide)15 mg
Choline (Choline Bitartrate)55 mg

Inactive Ingredients:


Croscarmellose Sodium, Colloidal Silicon Dioxide, Silicified Microcrystalline Cellulose, Magnesium Stearate, Citric Acid, Glycerol Monostearate, Triethyl Citrate, Polysorbate 80, Sodium Hydroxide, Methacrylic Acid Copolymer Dispersion, Polyacrylate Dispersion, Talc, Hypromellose, Triacetin, Polydextrose, Maltodextrin, FD&C Red #40 Aluminum Lake, Fractionated Coconut Oil, FD&C Blue #2 Aluminum Lake, Titanium Dioxide, Dextrose Monohydrate, Stearic Acid, Sodium Carboxymethylcellulose.



Each DHA gelatin capsule contains:











DHA is an omega-3 fatty acid. The DHA in Gesticare® DHA is derived from the oils of microalgae.


Other ingredients in the DHA gelatin capsule: Gelatin (bovine), Glycerine USP, High Oleic Sunflower Oil, Ascorbyl Palmitate, Tocopherols.


IngredientDose
Docosahexaenoic Acid (DHA)250 mg
Eicosapentaenoic Acid (EPA)Not more than 0.625mg

Patent Status:


U.S.Patents 5,407,957 & 5,492,938. Patent application #20070128272 pending.



Indications and Usage for Gesticare DHA


Gesticare® DHA is indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Gesticare® DHA is also beneficial in improving the nutritional status of women prior to conception.



Contraindications


This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.




WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.



Warnings

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.



Precautions


Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.



Adverse Reactions


Allergic sensitization has been reported following both oral and parenteral administration of folic acid.



Gesticare DHA Dosage and Administration


One Gesticare® delayed-release tablet and one DHA capsule daily or as directed by a physician.



How is Gesticare DHA Supplied


Gesticare® DHA 30 count (6 Blister Cards) is supplied as six child-resistant blister cards containing 5 Gesticare® delayed-release tablets and 5 DHA capsules each (NDC 18860-253-30).


Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°- 30ºC (59°-86°F).



KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.


RX only


Distributed by:


Azur Pharma, Inc.


1818 Market Street, Ste 2350


Philadelphia, PA 19103


To report a serious adverse event or obtain product information, contact (800) 890 3098.



life’s DHA is a trademark of Martek Biosciences Corporation.



PRINCIPAL DISPLAY PANEL - Carton label for blister cards


Gesticare® DHA Delayed-Release Prenatal Multi-Vitamin/Mineral Tablets

with DHA and Choline


NDC 18860-253-30 (30 Count)


6 Blister Cards; each containing

5 tablets and 5 capsules




PRINCIPAL DISPLAY PANEL - Carton label for physician’s sample


Gesticare® DHA Delayed-Release Prenatal Multi-Vitamin/Mineral Tablets

with DHA and Choline


Gesticare® DHA is indicated for use in improving the nutritional status

of women throughout pregnancy and in the postnatal period for

both lactating and nonlactating mothers.


Gesticare® DHA is also beneficial in improving the nutritional status of

women prior to conception.


PHYSICIAN'S SAMPLES (NDC 18860-253-00)


Contains 6 Patient Starter packages, each containing 2 tablets and 2 capsules


One tablet and one capsule daily or as directed by physician








































Gesticare DHA 
thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, choline bitartrate, doconexent, and icosapent  kit






Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)18860-253






















Packaging
#NDCPackage DescriptionMultilevel Packaging
118860-253-306 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
11 KIT In 1 BLISTER PACKThis package is contained within the CARTON (18860-253-30)
218860-253-006 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
21 KIT In 1 BLISTER PACKThis package is contained within the CARTON (18860-253-00)

















QUANTITY OF PARTS
Part #Package QuantityTotal Product Quantity
Part 1 
Part 2 
Part 3 
Part 4 



Part 1 of 4
GESTICARE 
thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, and choline bitartrate  tablet, delayed release










Product Information
   
Route of AdministrationORALDEA Schedule    















































Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
THIAMINE MONONITRATE (THIAMINE)THIAMINE MONONITRATE3 mg
RIBOFLAVIN (RIBOFLAVIN)RIBOFLAVIN3 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE)PYRIDOXINE HYDROCHLORIDE50 mg
CYANOCOBALAMIN (CYANOCOBALAMIN)CYANOCOBALAMIN8 ug
ASCORBIC ACID (ASCORBIC ACID)ASCORBIC ACID120 mg
NIACIN (NIACIN)NIACIN20 mg
FOLIC ACID (FOLIC ACID)FOLIC ACID1 mg
FERROUS FUMARATE (IRON)FERROUS FUMARATE27 mg
CALCIUM CARBONATE (CARBONATE ION)CALCIUM CARBONATE200 mg
CHOLECALCIFEROL (CHOLECALCIFEROL)CHOLECALCIFEROL410 [iU]
VITAMIN E ACETATE (VITAMIN E)VITAMIN E ACETATE30 [iU]
POTASSIUM IODIDE (IODINE)POTASSIUM IODIDE150 ug
ZINC OXIDE (ZINC OXIDE)ZINC OXIDE15 mg
CHOLINE BITARTRATE (CHOLINE)CHOLINE BITARTRATE55 mg












































Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
COLLOIDAL SILICON DIOXIDE 
MAGNESIUM STEARATE 
CITRIC ACID 
TRIETHYL CITRATE 
POLYSORBATE 80 
SODIUM HYDROXIDE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
TALC 
HYPROMELLOSES 
TRIACETIN 
POLYDEXTROSE 
MALTODEXTRIN 
FD&C RED NO. 40 
COCONUT OIL 
FD&C BLUE NO. 2 
TITANIUM DIOXIDE 
DEXTROSE MONOHYDRATE 
STEARIC ACID 


















Product Characteristics
Colorpink (P-114, light, coated)Scoreno score
ShapeCAPSULE (oblong)Size19mm
FlavorImprint Code
Contains      







Packaging
#NDCPackage DescriptionMultilevel Packaging
Package Information Not Applicable










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other09/01/2009




Part 2 of 4
DHA 
doconexent and icosapent  capsule, gelatin coated










Product Information
   
Route of AdministrationORALDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCONEXENT (DOCONEXENT)DOCONEXENT250 mg
ICOSAPENT (ICOSAPENT)ICOSAPENT0.625 mg












Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERIN 
SUNFLOWER OIL 
ASCORBYL PALMITATE 


















Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code
Contains      







Packaging
#NDCPackage DescriptionMultilevel Packaging
Package Information Not Applicable










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other09/01/2009




Part 3 of 4
GESTICARE 
thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, and choline bitartrate  tablet, delayed release










Product Information
   
Route of AdministrationORALDEA Schedule    















































Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
THIAMINE MONONITRATE (THIAMINE)THIAMINE MONONITRATE3 mg
RIBOFLAVIN (RIBOFLAVIN)RIBOFLAVIN3 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE)PYRIDOXINE HYDROCHLORIDE50 mg
CYANOCOBALAMIN (CYANOCOBALAMIN)CYANOCOBALAMIN8 ug
ASCORBIC ACID (ASCORBIC ACID)ASCORBIC ACID120 mg
NIACIN (NIACIN)NIACIN20 mg
FOLIC ACID (FOLIC ACID)FOLIC ACID1 mg
FERROUS FUMARATE (IRON)FERROUS FUMARATE27 mg
CALCIUM CARBONATE (CARBONATE ION)CALCIUM CARBONATE200 mg
CHOLECALCIFEROL (CHOLECALCIFEROL)CHOLECALCIFEROL410 [iU]
VITAMIN E ACETATE (VITAMIN E)VITAMIN E ACETATE30 [iU]
POTASSIUM IODIDE (IODINE)POTASSIUM IODIDE150 ug
ZINC OXIDE (ZINC OXIDE)ZINC OXIDE15 mg
CHOLINE BITARTRATE (CHOLINE)CHOLINE BITARTRATE55 mg












































Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
COLLOIDAL SILICON DIOXIDE 
MAGNESIUM STEARATE 
CITRIC ACID 
TRIETHYL CITRATE 
POLYSORBATE 80 
SODIUM HYDROXIDE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
TALC 
HYPROMELLOSES 
TRIACETIN 
POLYDEXTROSE 
MALTODEXTRIN 
FD&C RED NO. 40 
COCONUT OIL 
FD&C BLUE NO. 2 
TITANIUM DIOXIDE 
DEXTROSE MONOHYDRATE 
STEARIC ACID 


















Product Characteristics
Colorpink (P-114, light, coated)Scoreno score
ShapeCAPSULE (oblong)Size19mm
FlavorImprint Code
Contains      







Packaging
#NDCPackage DescriptionMultilevel Packaging
Package Information Not Applicable










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other09/01/2009




Part 4 of 4
DHA 
doconexent and icosapent  capsule, gelatin coated










Product Information
   
Route of AdministrationORALDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCONEXENT (DOCONEXENT)DOCONEXENT250 mg
ICOSAPENT (ICOSAPENT)ICOSAPENT0.625 mg












Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERIN 
SUNFLOWER OIL 
ASCORBYL PALMITATE 


















Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code
Contains      







Packaging
#NDCPackage DescriptionMultilevel Packaging
Package Information Not Applicable










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other09/01/2009











Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other10/01/2008


Labeler - Azur Pharma, Inc. (805611071)









Establishment
NameAddressID/FEIOperations
Pillar5 Pharma, Inc.243904344MANUFACTURE
Revised: 06/2011Azur Pharma, Inc.

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  • Vitamin/Mineral Supplementation during Pregnancy/Lactation

Gesticare


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

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


What are Gesticare (prenatal multivitamins)?

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


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


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


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


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


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


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

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


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

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


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

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


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

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


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

How should I take prenatal vitamins?


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


Never take more than the recommended dose of prenatal vitamins.

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


Take your prenatal vitamin with a full glass of water.

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


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


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


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

What happens if I miss a dose?


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


What happens if I overdose?


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

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


What should I avoid while taking prenatal vitamins?


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

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


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

Prenatal vitamins side effects


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

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



  • upset stomach;




  • headache; or




  • unusual or unpleasant taste in your mouth.



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


What other drugs will affect prenatal vitamins?


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



  • diuretics (water pills);




  • heart or blood pressure medications;




  • tretinoin (Vesanoid);




  • isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);




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




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



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



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  • Prenate Elite Prescribing Information (FDA)

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Compare Gesticare with other medications


  • Vitamin/Mineral Supplementation during Pregnancy/Lactation


Where can I get more information?


  • Your pharmacist can provide more information about prenatal vitamins.

See also: Gesticare side effects (in more detail)


Gentamicin Sulfate topical



Class: Antibacterials
ATC Class: D06AX07
VA Class: DE101
CAS Number: 1405-41-0

Introduction

Antibacterial;a b c d aminoglycoside antibiotic obtained from cultures of Micromonospora purpurea.c


Uses for Gentamicin Sulfate


Superficial Skin Infections


Topically to treat superficial skin infections caused by susceptible organisms.a b c d


Role of topical anti-infectives for treatment of superficial skin infections has not been fully elucidated.c


Treatment of serious or extensive skin infections usually requires systemic anti-infective therapy.c


Gentamicin Sulfate Dosage and Administration


General



  • Consider location of the lesion and condition being treated when choosing a dosage form.c




  • Creams are suitable for wet, oozing primary infections and greasy secondary infections or if a water-washable preparation is needed.a c d




  • Ointments help retain moisture and are suitable for dry, eczematous, or psoriatic skin.c d



Administration


Topical Administration


Apply cream or ointment topically to the skin;a b c d avoid contact with eyes.a b


May cover affected area with a sterile bandage following use of ointment or cream.a b c d


When treating impetigo, remove lesion crusts before applying gentamicin; use care to avoid further contamination of the infected skin.a b c d


Manufacturer states infected stasis ulcers may be treated with gentamicin under gelatin packaging.a b c d


Dosage


Available as gentamicin sulfate;a b c d dosage expressed in terms of gentamicin.c d


Pediatric Patients


Superficial Skin Infections

Topical

Children ≥1 year of age: Apply a small amount to lesions 3–4 times daily.a b c d


Adults


Superficial Skin Infections

Topical

Apply a small amount to lesions 3–4 times daily.a b c d


Special Populations


No special population dosage recommendations at this time.a b c d


Cautions for Gentamicin Sulfate


Contraindications



  • Known hypersensitivity to gentamicin or any ingredient in the formulation.a b c d



Warnings/Precautions


Sensitivity Reactions


Sensitization and photosensitivity reported following use of topical gentamicin.c d


Cross-Hypersensitivity

Cross-allergenicity occurs among the aminoglycosides; consider the possibility that patients who become sensitized to topical gentamicin may be sensitive to other topical and/or systemic aminoglycosides.c


Closely observe patients hypersensitive to other topical antibiotics; discontinue gentamicin if irritation or hypersensitivity occurs.c


General Precautions


Superinfection

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.a b c d Discontinue drug and institute appropriate therapy if superinfection occurs.a b c d


Cumulative Toxicity

Possible cumulative toxicity if applied topically to large skin lesions or large areas of denuded skin in combination with systemic aminoglycoside therapy.c


Specific Populations


Pregnancy

Category C.e


Lactation

Not known whether gentamicin is distributed into milk following topical application;e distributed into milk in small amounts following systemic administration.e


AAP classifies gentamicin as compatible with breast-feeding.e


Pediatric Use

Safety and efficacy not established in children <1 year of age.a b d


Common Adverse Effects


Erythema, pruritus.a b d


Gentamicin Sulfate Pharmacokinetics


Absorption


Bioavailability


Not usually absorbed from intact skin.c Readily absorbed from denuded areas of skin or skin that has lost the keratin layer (i.e., wounds, burns, ulcers).c


Greater absorption of gentamicin from cream than ointment.c


Stability


Storage


Topical


Cream and Ointment

15–30°C.a b d


Actions and SpectrumActions



  • Usually bactericidal.a b c d




  • Appears to inhibit protein synthesis in susceptible bacteria by irreversibly binding to 30S ribosomal subunits.c




  • Spectrum of activity includes many aerobic gram-negative bacteria and some aerobic gram-positive bacteria.c




  • Gram-positive aerobes: Active against Staphylococcus aureus.a d Minimally active against streptococci.c




  • Gram-negative aerobes: Active against Aerobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, and Pseudomonas aeruginosa.a b d




  • Inactive against fungi, viruses, and most anaerobic bacteria.a b c d




  • Resistance to gentamicin reported in both gram-positive and gram-negative bacteria.c Partial cross-resistance occurs between gentamicin and other aminoglycosides.c



Advice to Patients



  • Importance of discontinuing gentamicin and instituting appropriate therapy if superinfection occurs.a b c d




  • Importance of understanding that topical gentamicin preparations are for external use only; importance of not using in the eyes.a




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




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.




  • Importance of informing patients of other important precautionary information. (See Cautions.)



Preparations


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


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name


















Gentamicin Sulfate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Topical



Cream*



0.1% (of gentamicin)*



Gentamicin Sulfate (with parabens and propylene glycol)



Fougera, Perrigo



Ointment*



0.1% (of gentamicin)*



Gentamicin Sulfate (with parabens)



Fougera, Perrigo



Disclaimer

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


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

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions January 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



a. Fougera. Gentamicin sulfate cream prescribing information. Melville, NY; 2005 Mar.



b. Fougera. Gentamicin sulfate ointment prescribing information. Melville, NY; 1998 Mar. From the DailyMed website () Accessed 2007 Nov 20.



c. AHFS drug information 2007. McEvoy GK, ed. Gentamicin sulfate. Bethesda, MD: American Society of Health-System Pharmacists; 2007:3444-45.



d. Perrigo. Gentamicin sulfate ointment and cream prescribing information. Allegan, MI: 2007 Apr. From the DailyMed website () Accessed 2007 Nov 20 .



e. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Philadelphia: Lippincott Williams & Wilkins; 2005:720-3.



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  • Gentamicin Sulfate topical Use in Pregnancy & Breastfeeding
  • Gentamicin Sulfate topical Drug Interactions
  • Gentamicin Sulfate topical Support Group
  • 0 Reviews for Gentamicin Sulfate - Add your own review/rating


Compare Gentamicin Sulfate topical with other medications


  • Skin and Structure Infection