Aximad may be available in the countries listed below.
Cefotaxime sodium salt (a derivative of Cefotaxime) is reported as an ingredient of Aximad in the following countries:
International Drug Name Search
Class: Skin and Mucous Membrane Agents, Miscellaneous
VA Class: DE752
Chemical Name: 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid
Molecular Formula: C28H28O3
CAS Number: 106685-40-9
Brands: Differin
Retinoid; synthetic naphthoic acid-derivative.7 8 10 11 12 13 14 15 16 17 18 19 20 22
Treatment of acne vulgaris.1 4 5 6 7 11 12 13 14 16 17 18 19 20 21 22 31 32
Apply a thin film to skin as a cream, gel, or solution.1 4 5 7 11 12 13 16 17 18 19 20 21 22 31 32
Cleanse and dry the affected areas prior to application.1 31 32
Do not apply to eye(s), lips, angles of nose, or mucous membranes.1 31 32
A transient feeling of pruritus or burning may occur immediately after application.1 12 31 32 If increased sensitivity or irritation occurs, reduce frequency of application or, depending on the severity, discontinue use.1 31 32
Apparent exacerbation of acne that may occur during early weeks of therapy is attributable to the drug’s action on previously unseen lesions; do not discontinue.1 31 32
Excessive use does not increase therapeutic effects and may produce marked erythema, peeling, and discomfort.1 31 32
Remove single-use pledget applicators from foil immediately before use, use once, and then discard; do not use if seal is broken.31
Children and adolescents ≥12 years of age: Apply once daily in the evening at bedtime.1 12 31 32
Improvement usually detectable within 8–12 weeks.1 31 32
Apply once daily in the evening at bedtime.1 12 31 32
Improvement usually detectable within 8–12 weeks.1 31 32
Children and adolescents ≥12 years of age: most reported experience to date has been for treatment periods that did not exceed 12 weeks.4 5 6 12 22
Most reported experience to date has been for treatment periods that did not exceed 12 weeks.4 5 6 12 22
Known hypersensitivity to adapalene or any ingredient in the formulation.1 31 32
Increased risk for sunburn; minimize exposure to sunlight or artificial UV irradiation sources (e.g., sunlamps).1 31 32
Use caution in patients subjected to considerable occupational sun exposure or with inherent sun sensitivity; use of sunscreen products (SPF 15 or greater) and protective clothing over treated areas recommended when exposure cannot be avoided.1 31 32
Avoid concomitant use of photosensitizing agents.33 (See Interactions.)
Use not recommended in patients with sunburn until full recovery occurs.1 31
Discontinue therapy if sensitivity reaction or chemical irritation occurs.1 31 32
Erythema, dryness, scaling, burning, or pruritus may occur.1 31 32 If increased sensitivity or irritation occurs, use less frequently or, depending on the severity of the reaction, discontinue.1 31 32
Do not apply to cuts, abrasions, or eczematous or sunburned skin.1 31 32 (See Photosensitivity under Cautions.)
Use of mild or soapless cleanser is recommended; use medicated or drying soaps and abrasive soaps and cleansers with caution.1 31 32
Avoid use of irritating cosmetics, other preparations, or processes (e.g., electrolysis) that might dry or irritate the skin.33 (See Interactions.)
Possible increased skin irritation in patients exposed to environmental extremes (e.g., wind, cold).1 31 32
Use moisturizers if necessary; avoid preparations containing alpha hydroxy or glycolic acids.32
Category C.1 31 32
Not known whether adapalene is distributed into milk.1 31 32 Use caution.1 31 32
Safety and efficacy not established in children <12 years of age.1 31 32
Insufficient experience in controlled clinical studies in patients ≥65 years of age to determine whether geriatric patients respond differently to adapalene than younger adults.32 However, clinical experience generally has not revealed age-related differences.32
Erythema, scaling, dryness, pruritus, burning/stinging.1 31 32
Drug | Interaction | Comments |
|---|---|---|
Keratolytic agents (e.g., resorcinol, salicylic acid, sulfur) | Possible additive effects1 31 32 | Allow sufficient time for the effects of the keratolytic agent to subside before initiating adapalene1 31 32 |
Photosensitizing agents (e.g., fluoroquinolone anti-infectives, phenothiazines, sulfonamides, thiazide diuretics) | Possible increased phototoxicity33 | Avoid concomitant use33 |
Potential pharmacodynamic interaction (increased skin irritation).1 31 32 Avoid concurrent use of topical preparations with high concentrations of alcohol, menthol, spices, or lime (e.g., lotions, astringents, perfume); irritating cosmetics (e.g., toners, peeling [desquamating] agents); permanent wave solutions; or hair depilatories or waxes.1 31 32 33
Minimally absorbed following topical application.1 31 32
Eliminated principally by biliary excretion.1 31 32
20–25°C.1 31 32
Protect cream from freezing.32
Store solution upright in tight container.31
Actions similar to those of other retinoids (e.g., isotretinoin, tretinoin) but more potent anti-inflammatory activity in vitro and in vivo.1 4 5 6 9 13 15 16 17 19 23 24 31
Relatively selective affinity for specific nuclear retinoic acid receptor (RAR) proteins (e.g., RARβ, RARγ) that appear to enhance gene transcription.5 6 7 23 24
Exact mechanism(s) of action not elucidated.1 4 5 6 9 13 15 16 17 19 31 Appears to affect expression of genes that modulate follicular keratinization5 19 22 and cell (e.g., epithelial) differentiation,1 4 5 6 9 10 13 15 19 22 23 31 which result in inhibition of corneocyte accumulation and cohesion and reduction in inflammatory and noninflammatory acne lesions.1 6 11 12 22 23 24 31
Importance of clinicians instructing patients about proper use of the drug.1 31 32
Importance of continuing therapy in early weeks, even if acne initially appears to worsen.1 31 32
Risk of photosensitivity; importance of using sunscreens and wearing protective clothing over treated areas.1 31 32
Importance of avoiding contact with eyes, lips, angles of nose, or mucous membranes.1 31 32
Importance of not applying adapalene to cuts, abrasions, or eczematous or sunburned skin.1 31 32
Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed.1 31 32
Importance of patients informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 31 32
Importance of informing patients of other important precautionary information.1 31 32 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Cream | 0.1% | Differin (with parabens) | Galderma |
Gel | 0.1% | Differin (with methylparaben and propylene glycol) | Galderma | |
Pledgets (saturated with solution) | 0.1% | Differin (with SD alcohol 40-B 30% w/v) | Galderma | |
Solution | 0.1% | Differin (with SD alcohol 40-B 30% w/v) | Galderma |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Differin 0.1% Cream (GALDERMA): 45/$280 or 135/$829.96
Differin 0.1% Gel (GALDERMA): 45/$280 or 135/$829.96
Differin 0.3% Gel (GALDERMA): 45/$222 or 135/$630.01
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 February 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Galderma. Differin (adapalene) gel 0.1% prescribing information. Fort Worth, TX; 1996 May.
2. Hurwitz S. Acne vulgaris: current concepts of pathogenesis and treatment. Am J Dis Child. 1979; 133:536-44. [PubMed 155397]
3. Chandraratna RAS. Tazarotene—first of a new generation of receptor-selective retinoids. Br J Dermatol. 1996; 135:18-25.
4. Verschoore M, Langner A, Wolska H et al. Efficacy and safety of CD 271 alcoholic gels in the topical treatment of acne vulgaris. Br J Dermatol. 1991; 124:368-71. [IDIS 280987] [PubMed 1827344]
5. Shalita A, Weiss JS, Chalker DK et al. A comparison of the efficacy and safety of adapalene gel 0.1% and tretinoin gel 0.025% in the treatment of acne vulgaris: a multicenter trial. J Am Acad Dermatol. 1996; 34:482-5. [IDIS 364859] [PubMed 8609263]
6. Bernard BA. Adapalene, a new chemical entity with retinoid activity. Skin Pharmacol. 1993; 6(Suppl 1):61-9. [PubMed 8142113]
7. Griffiths CEM, Elder JT, Bernard BA et al. Comparison of CD271 (Adapalene) and all- trans retinoic acid in human skin: dissociation of epidermal effects and CRABP-II mRNA expression. J Invest Dermatol. 1993; 101:325-28. [PubMed 8396608]
8. Jamoulle JC, Grandjean L, Lamaud E et al. Follicular penetration and distribution of topically applied CD 271, a new naphthoic acid derivative intended for topical acne treatment. J Invest Dermatol. 1990; 94:731-2. [PubMed 2139085]
9. Hensby C, Cavey D, Bouclier M et al. The in vivo and in vitro anti- inflammatory activity of CD271: a new retinoid-like modulator of cell differentiation. Agents Actions. 1990; 29:56-8. [PubMed 2109510]
10. Bernerd F, Ortonne JP, Bouclier M et al. The rhino mouse model: the effects of topically applied all-trans retinoic acid and CD271 on the fine structure of the epidermis and utricle wall of pseudocomedones. Arch Dermatol Res. 1991; 283:100-7. [PubMed 2069410]
11. Leyden JJ. Therapy for acne vulgaris. N Engl J Med. 1997; 336:1156-62. [IDIS 388309] [PubMed 9099661]
12. Brogden RN, Goa KL. Adapalene: a review of its pharmacological properties and clinical potential in the management of mild to moderate acne. Drugs. 1997; 53:511-9. [PubMed 9074847]
13. Verschoore M. Adapalene: a novel topical retinoid receptor agonist for acne—overview. J Am Acad Dermatol. 1997; 36:S91.
14. Kligman AM. The treatment of acne with topical retinoids: one man’s opinions. J Am Acad Dermatol. 1997; 36:S92-5.
15. Shroot B, Michel S. Pharmacology and chemistry of adapalene. J Am Acad Dermatol. 1997; 36:S96-103. [PubMed 9204085]
16. Verschoore M, Poncet M, Czernielewski J et al. Adapalene 0.1% gel has low skin- irritation potential. J Am Acad Dermatol. 1997; 36:S104-9.
17. Caron D, Sorba V, Kerrouche N et al. Split-face comparison of adapalene 0.1% gel and tretinoin 0.025% gel in acne patients. J Am Acad Dermatol. 1997; 36:S110-12. [IDIS 389401] [PubMed 9204087]
18. Caron D, Sorba V, Clucas A et al. Skin tolerance of adapalene 0.1% gel in combination with other topical antiacne treatments. J Am Acad Dermatol. 1997; 36:S113-5.
19. Clucas A, Verschoore M, Sorba V et al. Adapalene 0.1% gel is better tolerated than tretinoin 0.025% gel in acne patients. J Am Acad Dermatol. 1997; 36:S116-8.
20. Allec J, Chatelus A, Wagner N. Skin distribution and pharmaceutical aspects of adapalene gel. J Am Acad Dermatol. 1997; 36:S119-25. [PubMed 9204090]
21. Cunliffe WJ, Caputo R, Dreno B et al. Clinical efficacy and safety comparison of adapalene gel and tretinoin gel in the treatment of acne vulgaris: Europe and U.S. multicenter trials. J Am Acad Dermatol. 1997; 36:S126-34. [IDIS 389404] [PubMed 9204091]
22. Anon. Adapalene for acne. Med Lett Drugs Ther. 1997; 39:19-20. [PubMed 9057779]
23. Thiboutot DM. Acne: an overview of clinical research findings. Dermatol Clin. 1997; 15:97-109. [PubMed 9001864]
24. Gibson JR. Rationale for the development of new topical treatments for acne vulgaris. Cutis. 1996; 57:13-9. [PubMed 8654127]
25. Anon. Update on birth defects with isotretinoin. FDA Drug Bull. 1984; 14:15-6. [PubMed 6592122]
26. Benke PJ. The isotretinoin teratogen syndrome. JAMA. 1984; 251:3267-9. [IDIS 186330] [PubMed 6587131]
27. de la Cruz E, Sun S, Vangvanichyakorn K et al. Multiple congenital malformations associated with maternal isotretinoin therapy. Pediatrics. 1984; 74:428-30. [IDIS 189774] [PubMed 6591112]
28. Lammer EJ, Chen DT, Hoar RM et al. Retinoic acid embryopathy. N Engl J Med. 1985; 313:837-41. [IDIS 204599] [PubMed 3162101]
29. Rosa FW, Wilk AL, Kelsey FO. Teratogen update: vitamin A congeners. Teratology. 1986; 33:355-64. [PubMed 3461576]
30. Cohen M, Rubenstein A, Li JK et al. Thymic hypoplasia associated with isotretinoin embryopathy. Am J Dis Child. 1987; 141:263-6. [IDIS 226304] [PubMed 3492909]
31. Galderma. Differin (adapalene) solution 0.1% prescribing information. Fort Worth, TX; 1997 Jul.
32. Galderma Laboratories. Differin cream 0.1% (adapalene) prescribing information. Fort Worth, TX; 2000 May.
33. Galderma Laboratories, Fort Worth, TX: Personal Communication.
Treating outer and some middle ear infections. It may also be used for other conditions as determined by your doctor.
Floxin Otic Solution is a fluoroquinolone antibiotic. It works by killing the bacteria.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Floxin Otic Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Floxin Otic Solution. However, no specific interactions with Floxin Otic Solution are known at this time.
Ask your health care provider if Floxin Otic 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.
Use Floxin Otic Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Floxin Otic 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:
Itching of the ear; taste changes.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased hearing; ear irritation; hearing loss; redness, bleeding, or swelling.
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: Floxin Otic side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Floxin Otic Solution may be harmful if swallowed.
Store Floxin Otic Solution at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Floxin Otic Solution out of the reach of children and away from pets.
This information is summary only. It does not contain all information about Floxin Otic 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.
Céfixime Arrow may be available in the countries listed below.
Cefixime trihydrate (a derivative of Cefixime) is reported as an ingredient of Céfixime Arrow in the following countries:
International Drug Name Search
Tikosyn may cause new irregular heart rhythms (arrhythmias). To reduce this risk, it is recommended that you stay in a facility with appropriate monitoring equipment for at least the first 3 days of therapy.
Maintaining normal heart rhythm in patients with certain irregular heart rhythms. It may also be used for other conditions as determined by your doctor.
Tikosyn is an antiarrhythmic. It works by blocking certain heart currents, which allows the heart to regain a normal rhythm.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Tikosyn. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Tikosyn. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Tikosyn 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.
Use Tikosyn as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Tikosyn.
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:
Dizziness; headache; nausea; respiratory tract infection.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; difficulty breathing; fast, slow, or irregular heartbeat; fainting; heart attack; pale stool; paralysis; pounding in the chest; stopping of the heart; sudden death; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Tikosyn side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Tikosyn at room temperature, 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 Tikosyn out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Tikosyn. 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.
Generic Name: tretinoin topical (TRET in oin)
Brand Names: Altinac, Atralin, Avita, Renova, Retin A Micro Gel, Retin-A, Tretin-X
Tretinoin is a topical (applied to the skin) form of vitamin A that helps the skin renew itself.
The Retin-A and Avita brands of tretinoin are used to treat acne. The Renova brand of tretinoin is used to reduce the appearance of fine wrinkles and mottled skin discoloration, and to make rough facial skin feel smoother.
Tretinoin topical may also be used for other purposes not listed in this medication guide.
Use tretinoin topical exactly as your doctor has prescribed it for you. Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects. Do not use this medication for longer than your doctor has prescribed.
Applying tretinoin topical to wet skin may cause skin irritation. If you use Renova, wait at least 20 minutes after washing your face before applying a thin layer of the medication.
Do not wash the treated area for at least 1 hour after applying tretinoin topical. Avoid the use of other skin products on the treated area for at least 1 hour following application of tretinoin topical.
Applying an excessive amount of tretinoin gel may result in "pilling" of the medication. If this occurs, use a thinner layer of gel with the next application.
Tretinoin topical should be used as part of a complete skin care program that includes avoiding sunlight and using an effective sunscreen and protective clothing.
Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not apply extra medicine to make up the missed dose.
Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medication skin products unless your doctor has told you to.
Your skin may be more sensitive to weather extremes such as cold and wind while using this medicine.
Less serious side effects may include burning, warmth, stinging, tingling, itching, redness, swelling, dryness, peeling, irritation, or discolored skin.
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.
The following drugs can interact with tretinoin topical, which can make your skin more sensitive to natural and artificial sunlight. Before using this medication, tell your doctor if you are using any of these:
a diuretic (water pill);
tetracycline (Sumycin, Panmycin, Robitet), minocycline (Minocin), doxycycline (Doryx, Vibramycin), demeclocycline (Declomycin), and others;
an antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), and others;
a sulfa drug such as Bactrim, Septra, Cotrim, and others; or
chlorpromazine (Thorazine), prochlorperazine (Compazine), fluphenazine (Permitil, Prolixin), promethazine (Phenergan, Promethegan), perphenazine (Trilafon), and others.
This list is not complete and there may be other drugs that can affect tretinoin topical. 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.
See also: Altinac side effects (in more detail)
Ceforal may be available in the countries listed below.
Cefadroxil is reported as an ingredient of Ceforal in the following countries:
Cefalexin monohydrate (a derivative of Cefalexin) is reported as an ingredient of Ceforal in the following countries:
International Drug Name Search
Generic Name: haemophilus b conjugate (PRP-T) vaccine (hem OFF il us B KON ju gate)
Brand Names: ActHIB, Hiberix
Haemophilus B is a type of influenza (flu) caused by bacteria.
Haemophilus B bacteria can infect the lungs or throat, and can also spread to the blood, bones, joints, brain, or spinal cord. It can cause breathing problems or meningitis, and these infections can be fatal.
Haemophilus B disease can spread from one person to another through small droplets of saliva that are expelled into the air when an infected person coughs or sneezes. The bacteria can also be passed through contact with objects the infected person has touched, such as a door handle, or other surface. The bacteria can also be passed through kissing, or sharing a drinking glass or eating utensil with an infected person.
Haemophilus B conjugate vaccine is used to prevent infection caused by haemophilus B bacteria, and is sometimes combined with vaccines to protect against other diseases. Haemophilus B vaccine will not protect against other types of influenza.
Haemophilus B conjugate vaccine works by exposing your child to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.
Like any vaccine, haemophilus B conjugate vaccine may not provide protection from disease in every person.
The haemophilus B conjugate vaccine is given in a series of shots. In most cases, this vaccine is given as 2 separate shots, 2 months apart. A booster dose is then given 2 months after the last shot, or no later than 18 months of age.
Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.
Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.
Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.
Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with haemophilus B is much more dangerous to your child's health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Before receiving haemophilus B conjugate vaccine, tell your child's doctor if the child is allergic to any drugs, or has:
a bleeding or blood clotting disorder such as hemophilia or easy bruising;
a history of seizures;
a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);
an allergy to latex rubber;
a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or
if the child is taking a blood thinner such as warfarin (Coumadin).
This vaccine is given as an injection (shot) into a muscle. Your child will receive this injection in a doctor's office or other clinic setting.
Haemophilus B conjugate vaccine is given to children between the ages of 2 months and 18 months old. It may also be given to an older child with a medical conditions such as HIV or AIDS, sickle cell disease, or who is receiving cancer treatments or a bone marrow transfusion.
The haemophilus B conjugate vaccine is given in a series of shots. In most cases, this vaccine is given as 2 separate shots, 2 months apart. A booster dose is then given 2 months after the last shot, or no later than 4 years of age.
Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.
Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.
Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.
It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.
Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.
Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.
An overdose of this vaccine is not likely to occur.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Becoming infected with haemophilus B is much more dangerous to your child's health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
extreme drowsiness, fainting;
fussiness, irritability, crying for an hour or longer;
seizure (black-out or convulsions); or
high fever (within a few hours or a few days after the vaccine).
Less serious side effects may include:
redness, pain, swelling, or a lump where the shot was given;
low fever;
mild fussiness or crying;
joint pain, body aches;
drowsiness; or
diarrhea.
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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
Also tell the doctor if your child has recently received drugs or treatments that can weaken the immune system, including:
an oral, nasal, inhaled, or injectable steroid medicine;
medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or
medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).
This list is not complete and there may be other drugs that can interact with haemophilus B conjugate vaccine. Tell your doctor about all the prescription and over-the-counter medications your child uses. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your child's doctor.
See also: ActHIB side effects (in more detail)
Revised APRIL 2008
11001320
Rx only
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
Dextroamphetamine sulfate is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, Dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of Dextroamphetamine sulfate as the neutral sulfate. The structural formula is as follows:
(C9H13N)2∙H2SO4 Molecular Weight: 368.49
Calcium sulfate, colloidal silicon dioxide, compressible sugar, magnesium stearate, microcrystalline cellulose, and starch.
The 5 mg also contains D&C yellow no. 10 aluminum lake and FD&C red no. 40 aluminum lake.
The 10 mg also contains FD&C red no. 40 aluminum lake and FD&C yellow no. 6 aluminum lake.
Amphetamines are non-catecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action.
There is neither specific evidence which clearly establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.
Pharmacokinetics:
The pharmacokinetics of the tablet and sustained-release capsule were compared in 12 healthy subjects. The extent of bioavailability of the sustained-release capsule was similar compared to the immediate-release tablet. Following administration of three 5 mg tablets, average maximal Dextroamphetamine plasma concentrations (Cmax) of 36.6 ng/mL were achieved at approximately 3 hours. Following administration of one 15 mg sustained-release capsule, maximal Dextroamphetamine plasma concentrations were obtained approximately 8 hours after dosing. The average Cmax was 23.5 ng/mL. The average plasma T1/2 was similar for both the tablet and sustained-release capsule and was approximately 12 hours.
In 12 healthy subjects, the rate and extent of Dextroamphetamine absorption were similar following administration of the sustained-release capsule formulation in the fed (58 to 75 gm fat) and fasted state.
Dextroamphetamine sulfate tablets are indicated for:
Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.
Agitated states.
Patients with a history of drug abuse.
During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).
Serious Cardiovascular Events
Sudden Death in Patients with Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems: Children and Adolescents: Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
Adults: Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs (see CONTRAINDICATIONS).
Hypertension and Other Cardiovascular Conditions: Stimulant medications cause a modest increase in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia (see CONTRAINDICATIONS).
Assessing Cardiovascular Status in Patients Being Treated With Stimulant Medications: Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.
Psychiatric Adverse Events
Pre-Existing Psychosis: Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
Bipolar Illness: Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
Emergence of New Psychotic or Manic Symptoms: Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3,482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.
Aggression: Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of, or worsening of, aggressive behavior or hostility.
Long-Term Suppression of Growth: Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
Seizures: There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.
Visual Disturbance: Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.
Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly.
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Dextroamphetamine and should counsel them in its appropriate use. A patient Medication Guide is available for Dextroamphetamine. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of amphetamines. Urinary acidifying agents (ammonium chloride, sodium acid phosphate, etc.) increase the concentration of the ionized species of the amphetamine molecule, thereby increasing urinary excretion. Both groups of agents lower blood levels and efficacy of amphetamines.
Adrenergic blockers are inhibited by amphetamines.
Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines. Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion. Both groups of agents increase blood levels and therefore potentiate the actions of amphetamines.
Amphetamines may enhance the activity of tricyclic or sympathomimetic agents; d-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.
MAOI antidepressants, as well as a metabolite of furazolidone, slow amphetamine metabolism. This slowing potentiates amphetamines, increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings; this can cause headaches and other signs of hypertensive crisis. A variety of neurological toxic effects and malignant hyperpyrexia can occur, sometimes with fatal results.
Amphetamines may counteract the sedative effect of antihistamines.
Amphetamines may antagonize the hypotensive effects of antihypertensives.
Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning.
Amphetamines may delay intestinal absorption of ethosuximide.
Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines.
The stimulatory effects of amphetamines may be inhibited by lithium carbonate.
Amphetamines potentiate the analgesic effect of meperidine.
Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine therapy.
Amphetamines enhance the adrenergic effect of norepinephrine.
Amphetamines may delay intestinal absorption of phenobarbital; co-administration of phenobarbital may produce a synergistic anticonvulsant action.
Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic anticonvulsant action.
In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.
Amphetamines inhibit the hypotensive effect of veratrum alkaloids.
Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of Dextroamphetamine sulfate have not been performed.
Pregnancy Category C. Dextroamphetamine has been shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose. Embryotoxic effects were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose. While there are no adequate and well-controlled studies in pregnant women, there has been one report of severe congenital bony deformity, tracheoesophageal fistula, and anal atresia (Vater association) in a baby born to a woman who took Dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. Dextroamphetamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.
Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.
Long-term effects of amphetamines in pediatric patients have not been well established.
Amphetamines are not recommended for use in pediatric patients under 3 years of age with Attention Deficit Disorder with Hyperactivity described under INDICATIONS AND USAGE.
Clinical experience suggests that in psychotic pediatric patients, administration of amphetamines may exacerbate symptoms of behavior disturbance and thought disorder.
Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette's syndrome in pediatric patients and their families should precede use of stimulant medications.
Data are inadequate to determine whether chronic administration of amphetamines may be associated with growth inhibition; therefore, growth should be monitored during treatment.
Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should be considered only in light of the complete history and evaluation of the pediatric patient. The decision to prescribe amphetamines should depend on the physician's assessment of the chronicity and severity of the pediatric patient's symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.
When these symptoms are associated with acute stress reactions, treatment with amphetamines is usually not indicated.
Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.
Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics and Tourette's syndrome.
Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.
Urticaria.
Impotence, changes in libido.
Dextroamphetamine sulfate is a Schedule II controlled substance.
Amphetamines have been extensively abused. Tolerance, extreme psychological dependence and severe social disability have occurred. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG.
Manifestations of chronic intoxication with amphetamines include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. This is rare with oral amphetamines.
Individual patient response to amphetamines varies widely. While toxic symptoms occasionally occur as an idiosyncrasy at doses as low as 2 mg, they are rare with doses of less than 15 mg;
30 mg can produce severe reactions, yet doses of 400 to 500 mg are not necessarily fatal.
In rats, the oral LD50 of Dextroamphetamine sulfate is 96.8 mg/kg.
Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rhabdomyolysis, rapid respiration, hyperpyrexia, confusion, assaultiveness, hallucinations, panic states.
Fatigue and depression usually follow the central stimulation.
Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.
Consult with a Certified Poison Control Center for up-to-date guidance and advice. Management of acute amphetamine intoxication is largely symptomatic and includes gastric lavage, administration of activated charcoal, administration of a cathartic, and sedation. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Acidification of the urine increases amphetamine excretion, but is believed to increase risk of acute renal failure if myoglobinuria is present. If acute, severe hypertension complicates amphetamine overdosage, administration of intravenous phentolamine has been suggested. However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved.
Chlorpromazine antagonizes the central stimulant effects of amphetamines and can be used to treat amphetamine intoxication.
Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of the resulting insomnia.
Usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.
Narcolepsy seldom occurs in children under 12 years of age; however, when it does, Dextroamphetamine sulfate may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until an optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.
Not recommended for pediatric patients under 3 years of age.
In pediatric patients from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.
In pediatric patients 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day.
Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.
Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.
Dextroamphetamine Sulfate Tablets, USP are available as:
5 mg: Peach, round, flat-faced, beveled-edge, scored tablet. Debossed with 952/5 on the scored side and stylized b on the other side. Available in bottles of:
100 NDC 0555-0952-02
10 mg: Pink, round, flat-faced, beveled-edge, scored tablet. Debossed with 953/10 on the scored side and stylized b on the other side. Available in bottles of:
100 NDC 0555-0953-02
Dispense in a tight, light-resistant container.
Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
DEA Order Form Required.
Dextroamphetamine SULFATE TABLETS - CII
Read the Medication Guide that comes with Dextroamphetamine Sulfate Tablets before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about you or your child’s treatment with Dextroamphetamine Sulfate Tablets.
What is the most important information I should know about Dextroamphetamine Sulfate Tablets?
The following have been reported with use of Dextroamphetamine Sulfate Tablets and other stimulant medicines.
1. Heart-related problems:
Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
Your doctor should check you or your child carefully for heart problems before starting Dextroamphetamine Sulfate Tablets.
Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Dextroamphetamine Sulfate Tablets.
Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Dextroamphetamine Sulfate Tablets.
2. Mental (Psychiatric) problems:
All Patients
Children and Teenagers
Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Dextroamphetamine Sulfate Tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
What are Dextroamphetamine Sulfate Tablets?
Dextroamphetamine Sulfate Tablets are a central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Dextroamphetamine Sulfate Tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Dextroamphetamine Sulfate Tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Dextroamphetamine Sulfate Tablets are also used in the treatment of a sleep disorder called narcolepsy.
Dextroamphetamine Sulfate is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Dextroamphetamine Sulfate Tablets in a safe place to prevent misuse and abuse. Selling or giving away Dextroamphetamine Sulfate Tablets may harm others, and is against the law.
Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.
Who should not take Dextroamphetamine Sulfate Tablets?
Dextroamphetamine Sulfate Tablets should not be taken if you or your child:
Dextroamphetamine Sulfate Tablets are not recommended for use in children less than 3 years old.
Dextroamphetamine Sulfate Tablets may not be right for you or your child. Before starting Dextroamphetamine Sulfate Tablets tell your or your child’s doctor about all health conditions (or a family history of) including:
Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.
Can Dextroamphetamine Sulfate Tablets be taken with other medicines?
Tell your doctor about all of the medicines that you or your child take including prescription and non-prescription medicines, vitamins, and herbal supplements.
Dextroamphetamine Sulfate Tablets and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Dextroamphetamine Sulfate Tablets.
Your doctor will decide whether Dextroamphetamine Sulfate Tablets can be taken with other medicines.
Especially tell your doctor if you or your child take:
Know the medicines that you or your child take. Keep a list of your medicines with you to show your doctor and pharmacist.
Do not start any new medicine while taking Dextroamphetamine Sulfate Tablets without talking to your doctor first.
How should Dextroamphetamine Sulfate Tablets be taken?
What are possible side effects of Dextroamphetamine Sulfate Tablets?
See “What is the most important information I should know about Dextroamphetamine Sulfate Tablets?” for information on reported heart and mental problems.
Other serious side effects include:
Common side effects include:
Dextroamphetamine Sulfate Tablets may affect your or your child’s ability to drive or do other dangerous activities.
Talk to your doctor if you or your child have side effects that are bothersome or do not go away.
This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Dextroamphetamine Sulfate Tablets?
General information about Dextroamphetamine Sulfate Tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Dextroamphetamine Sulfate Tablets for a condition for which they were not prescribed. Do not give Dextroamphetamine Sulfate Tablets to other people, even if they have the same condition. It may harm them and it is against the law. This Medication Guide summarizes the most important information about Dextroamphetamine Sulfate Tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Dextroamphetamine Sulfate Tablets that was written for healthcare professionals. For more in formation about Dextroamphetamine Sulfate Tablets, please contact Barr Laboratories, Inc. at 1-800-BARRLAB (227-7522).
What are the ingredients in Dextroamphetamine Sulfate Tablets?
Active Ingredients: Dextroamphetamine sulfate
calcium sulfate, colloidal silicon dioxide, compressible sugar, magnesium stearate, microcrystalline cellulose, and starch.
The 5 mg also contains D&C yellow no. 10 aluminum lake and FD&C red no. 40 aluminum lake.
The 10 mg also contains FD&C red no. 40 aluminum lake and FD&C yellow no. 6 aluminum lake.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
BARR LABORATORIES, INC.
Pomona, NY 10970
Revised APRIL 2008
BR-0952, 0953
barr
CII
Dextroamphetamine
Sulfate
Tablets, USP
5 mg
Pharmacist: Dispense with
Medication Guide.
100 Tablets
Rx only
barr
CII
Dextroamphetamine
Sulfate
Tablets, USP
10 mg
Pharmacist: Dispense with
Medication Guide.
100 Tablets
Rx only
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| ANDA | ANDA040361 | 11/18/2010 | |
