Synthroid

Pronunciation: LEE-voe-thye-ROX-een
Generic Name: Levothyroxine
Brand Name: Examples include Levoxyl and Synthroid

Do not use Synthroid alone or with other medicines to treat obesity or to lose weight. Incorrect use of Synthroid may cause serious and sometimes fatal side effects.

Synthroid is used for:

Treating low thyroid hormone levels and certain types of goiters. It is also used with surgery and other medicines for managing certain types of thyroid cancer. It may also be used for other conditions as determined by your doctor.

Synthroid is a thyroid hormone. It works by replacing thyroid hormone when your body does not make enough on its own.

Do NOT use Synthroid if:

• you are allergic to any ingredient in Synthroid


• you have untreated adrenal gland problems or high thyroid hormone levels


• you have had a recent heart attack

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

Before using Synthroid:

Some medical conditions may interact with Synthroid. 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 trouble swallowing, heart or blood vessel problems (eg, coronary artery disease), high blood pressure, blood clotting or bleeding problems, pernicious anemia, diabetes, bone problems (eg, osteoporosis), fertility problems, pituitary problems, adrenal gland problems, or other thyroid problems


• if you have problems absorbing nutrition from your stomach or intestines into your body


• if you had a recent surgery or have an upcoming surgery

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

• Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, nasal congestion, asthma, high blood pressure, irregular heartbeat or other heart problems, blood thinning, mental or mood problems, depression, diabetes, other thyroid problems, high cholesterol, hepatitis, weight loss, heartburn, birth control, hormone replacement therapy, growth hormone deficiency, cancer, seizures), and multivitamin products may interact with Synthroid, increasing the risk of side effects or decreasing effectiveness.

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

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

• Take Synthroid by mouth on an empty stomach at least one-half to one hour before breakfast.


• Some brands of Synthroid must be taken with a full glass of water (8 oz/240 mL). Ask your pharmacist how you should take your brand of Synthroid.


• Do not take an antacid or a product that has iron or calcium in it within 4 hours of taking Synthroid.


• If the patient is a child or if you cannot swallow the tablet whole, you may crush the correct dose of the medicine. Add the crushed medicine to 1 to 2 teaspoons (5 to 10 mL) of water. Mix well. Use a spoon or dropper to give the medicine as soon as possible. Do not store the mixture for later use. Do not mix crushed tablets in soybean infant formula. Ask your pharmacist if you have any questions.


• Synthroid works best if it is taken at the same time each day.


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


• It may take several weeks before you notice an improvement in your symptoms. Do not stop or change your dose of Synthroid without first checking with your doctor.


• If you miss a dose of Synthroid, 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 Synthroid.

Important safety information:

• Some brands of Synthroid may cause choking, gagging, or trouble swallowing. Ask your pharmacist if your brand may cause these effects. If your brand may cause these effects, be sure to take your medicine with a full glass of water. Tell your doctor if you have trouble swallowing.


• It is important to take Synthroid exactly as prescribed. Do not take more than the prescribed dose without checking with your doctor.


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


• Diabetes patients - Synthroid may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Foods that contain soybean flour (including infant formula), cottonseed meal, walnuts, or dietary fiber may decrease the absorption of Synthroid. Tell your doctor if your diet includes any of these foods. Your doctor may need to change your dose of Synthroid.


• Mild hair loss may rarely occur during the first few months of treatment with Synthroid. This is usually temporary. Contact your doctor if hair loss is severe or persistent.


• Lab tests, including thyroid hormone level and growth checks, may be performed while you use Synthroid. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Synthroid with caution in the ELDERLY; they may be more sensitive to its effects, especially heart problems.


• CHILDREN and teenagers may need regular growth checks while they take Synthroid.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. Your doctor may need to change your dose of Synthroid. Synthroid is found in breast milk. If you are or will be breast-feeding while you use Synthroid, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Synthroid:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with the use of Synthroid. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; flushing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); changes in appetite; changes in menstrual periods; chest pain; diarrhea; excessive sweating; fast or irregular heartbeat; fever; heat intolerance; joint pain; leg cramps; mental or mood changes (eg, anxiety, irritability, nervousness); muscle weakness; seizures; severe or persistent headache or fatigue; shortness of breath; stomach cramps; tremors; trouble sleeping; unusual weight gain or weight loss; vomiting; wheezing.

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: Synthroid 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 coma; confusion; disorientation; seizures.

Proper storage of Synthroid:

Store Synthroid between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Protect from heat, light, and moisture. Do not store in the bathroom. Keep Synthroid out of the reach of children and away from pets.

General information:

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


• Synthroid 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 Synthroid. 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 Synthroid resources

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

• Synthroid Prescribing Information (FDA)


• Synthroid Advanced Consumer (Micromedex) - Includes Dosage Information


• Synthroid Consumer Overview


• Levothyroxine Prescribing Information (FDA)


• Levothroid Prescribing Information (FDA)


• Levothyroxine Sodium Monograph (AHFS DI)


• Levoxyl Prescribing Information (FDA)


• Levoxyl Consumer Overview


• Tirosint Prescribing Information (FDA)

Compare Synthroid with other medications

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• Myxedema Coma
• Thyroid Suppression Test
• TSH Suppression
• Underactive Thyroid

Sodium Iodide I 131

Sodium Iodide I-131 Solution


Rx Only.

DESCRIPTION

Sodium Iodide I-131 (Na 131I) for therapeutic use is available as a stabilized aqueous solution for oral administration. The solution is available in screw-cap vials with radioactivity ranging from 185 to 5550 megabecquerels (5.0 to 150 millicuries) per vial at the time of calibration. The solution contains 0.1% sodium bisulfite and 0.2% edetate disodium as stabilizers, 0.5% sodium phosphate anhydrous as a buffer and sodium iodide I-131 at concentrations of 185 or 925 megabecquerels (5.0 or 25.0 millicuries) per milliliter. The pH has been adjusted to between 7.5 and 9.0. The iodine I-131 utilized in the preparation of the solution contains not less than 99% Iodine I-131 at the time of calibration.

Physical Characteristics

Iodine I-131 decays by beta emission and associated gamma emission with a physical half-life of 8.04 days1. The principal beta emissions and gamma photons are listed in Table 1.

Table 1. Principal Radiation Emission Data

Radiation	Mean Percent Per Disintegration	Energy (keV)
Beta-1	2.12	69.4 Avg.
Beta-3	7.36	96.6 Avg.
Beta-4	89.3	191.6 Avg.
Gamma-7	6.05	284.3
Gamma-14	81.2	364.5
Gamma-17	7.26	637.0

External Radiation

The specific gamma ray constant for iodine I-131 is 2.27 R/hr-mCi at 1 cm. The first half-value thickness of lead (Pb) for iodine I-131 is 0.24 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 4.6 cm of Pb will decrease the external radiation exposure by a factor of about 1,000.

Table 2. Radiation Attenuation by Lead Shielding*

Shield Thickness (Pb), cm	Coefficient of Attenuation
* Data supplied by Oak Ridge Associated Universities, Radiopharmaceutical Internal Dose Information Center, Oak Ridge, TN, 1987.
0.24	0.5
0.95	10-1
2.6	10-2
4.6	10-3
6.5	10-4

To correct for physical decay of this radionuclide, the fractions that remain at selected time intervals after the date of calibration are shown in Table 3.

Table 3. Physical Decay Chart, Iodine I-131, Half-Life 8.04 Days

* Calibration Day
Days	Fraction Remaining	Days	Fraction Remaining
0*	1.000	16	0.252
1	0.917	17	0.231
2	0.842	18	0.212
3	0.772	19	0.194
4	0.708	20	0.178
5	0.650	21	0.164
6	0.596	22	0.150
7	0.547	23	0.138
8	0.502	24	0.126
9	0.460	25	0.116
10	0.422	26	0.106
11	0.387	27	0.098
12	0.355	28	0.089
13	0.326	29	0.082
14	0.299	30	0.075
15	0.274

1

Kocher, David C., “Radioactive Decay Data Tables”, DOE/TIC 11026, page 133 (1981).

Sodium Iodide I 131 - Clinical Pharmacology

Sodium Iodide is readily absorbed from the gastrointestinal tract. Following absorption, the iodide is distributed primarily within the extracellular fluid of the body. It is concentrated and organified by the thyroid, and trapped but not organified by the stomach and salivary glands. It is also promptly excreted by the kidneys. About 90% of local irradiation is the result of beta radiation and 10% is the result of gamma radiation.

Indications and Usage for Sodium Iodide I 131

Sodium Iodide I-131 Therapeutic may be indicated in the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid. Palliative effects maybe seen in patients with papillary and/or follicular carcinoma of the thyroid. Stimulation of radioiodide uptake may be achieved by the administration of thyrotropin. (Radioiodide will not be taken up by giant cell and spindle cell carcinoma of the thyroid nor by amyloid solid carcinomas.)

Contraindications

Vomiting and diarrhea represent contraindications to the use of radioiodide.

Therapeutic doses of Sodium Iodide I-131 may cause fetal harm when administered to a pregnant woman. Therapeutic doses of Sodium Iodide I-131 are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazards to the fetus.

Warnings

Contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Sodium Iodide I-131 is not usually used for treatment of hyperthyroidism in patients under 30 years of age.

Precautions

General

The uptake of radioiodide will be affected by recent intake of stable iodine in any form, or by the use of thyroid, anti-thyroid, and certain other drugs. Accordingly, the patient should be questioned carefully regarding previous medication and procedures involving radiographic contrast media.

The expiration date is not later than one month after the calibration date. The calibration date and the expiration date are stated on the label.

As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient, consistent with proper patient management, and to insure minimum radiation exposure to occupational workers.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or whether this drug affects fertility in males or females.

Pregnancy Category X

See CONTRAINDICATIONS section.

Radioiodide therapy in women of childbearing capability should only be performed when appropriate contraceptive measures have been taken or when pregnancy testing is negative.

Nursing Mothers

Radioiodine is excreted in human milk during lactation. Therefore, formula feedings should be substituted for breast feedings.

Pediatric Use

See WARNINGS section.

Adverse Reactions

Although rare, reactions have been reported following the administration of iodine-containing radiopharmaceuticals including, in decreasing order of frequency, nausea, vomiting, chest pain, tachycardia, itching skin, rash, and hives. Depression of the hematopoietic system may occur when large doses are employed. Such potential side effects include radiation sickness, increase in clinical symptoms, bone marrow depression, acute leukemia, anemia, chromosomal abnormalities, acute thyroid crisis, blood dyscrasia, leukopenia, thrombocytopenia, and death.

Sodium Iodide I 131 Dosage and Administration

Antithyroid therapy of a severely hyperthyroid patient is usually discontinued three to four days before administration of radioiodide.

For hyperthyroidism, the usual dose range is 148 to 370 megabecquerels (4 to 10 millicuries). Toxic nodular goiter and other special situations will require the use of larger doses.

For thyroid carcinoma, 1850 megabecquerels (50 millicuries) is the usual dose for ablation of normal thyroid tissue, and 3700 to 5550 megabecquerels (100 to 150 millicuries) is the usual subsequent therapeutic dose.

Waterproof gloves should be used during the entire handling and administration procedure. Adequate shielding should be maintained during the life of the product.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Radiation Dosimetry

The estimated absorbed radiation doses2 to an average (70 kg) euthyroid (normal functioning thyroid) patient from an oral dose of Iodine I-131 in both milligrays per megabecquerel and rads per millicurie are shown in Table 4.

Table 4. Absorbed Radiation Doses

Thyroid Uptake
Tissue	5%		15%		25%
	mGy/ MBq	rads/ mCi	mGy/ MBq	rads/ mCi	mGy/ MBq	rads/ mCi
Thyroid	70.3	260	216.2	800	351.4	1300
Stomach Wall	0.459	1.7	0.432	1.6	0.378	1.4
Red Marrow	0.038	0.14	0.054	0.20	0.070	0.26
Liver	0.054	0.20	0.095	0.35	0.130	0.48
Testes	0.023	0.084	0.023	0.085	0.024	0.088
Ovaries	0.038	0.14	0.038	0.14	0.038	0.14
Total Body	0.065	0.24	0.127	0.47	0.192	0.71

2

MIRD DOSE ESTIMATE REPORT No. 5 Summary and Current Radiation Dose Estimates to Humans from 123I, 124I, 125I, 126I, 130I, 131I, and 132I, Sodium Iodide. J. Nucl. Med., 16, No. 9, 857-60 (1975).

How is Sodium Iodide I 131 Supplied

Catalog Number 450.

Sodium Iodide I-131 solution for therapeutic use by oral administration is available in shielded, screw-cap vials containing the following quantities of iodine I-131.

Concentration*	Volume of Solution	Total Radioactivity* per Vial
* At Time of Calibration
185 MBq/mL	1 mL	185 MBq (5 mCi)
(5.0 mCi/mL)	2 mL	370 MBq (10 mCi)
	3 mL	555 MBq (15 mCi)
	4 mL	740 MBq (20 mCi)
	5 mL	925 MBq (25 mCi)
	7 mL	1295 MBq (35 mCi)
925 MBq/mL	2 mL	1850 MBq (50 mCi)
(25.0 mCi/mL)	3 mL	2775 MBq (75 mCi)
	4 mL	3700 MBq (100 mCi)
	6 mL	5550 MBq (150 mCi)

STORAGE AND HANDLING

Sodium Iodide I-131 Therapeutic Solution should be stored at controlled room temperature 20° to 25°C (68° to 77°F).

Storage and disposal of Sodium Iodide I-131 Solution should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.

The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use by-product material listed in Section 35.300, and to persons who hold an equivalent license issued by an Agreement State.

Rev 101806

Mallinckrodt Inc.

St. Louis, MO 63134

tyco

Healthcare

Mallinckrodt

A450I0

PRINCIPAL DISPLAY PANEL

Sodium Iodide I 131 SOLUTION

THERAPEUTIC

For Oral Use Only

Store at Controlled Room Temperature 20 to 25°C (68 to 77°F).

Contains 0.1% sodium bisulfate and 0.2% edetate disodium as stabilizers and 0.5% dibasic sodium phosphate anhydrous as a buffer. The pH is between 7.5 and 9.0

For information on dosage, administration and indications see package insert.

Rx Only.

WARNING: Radioactive drugs must be handled only by qualified personnel in conformity with regulations of the U.S. Nuclear Regulatory Commission or state regulatory agencies where applicable. Bottle containing drug should be kept in this container or within heavier shield.

In Canada:

Mallinckrodt Canada Inc.

Pointe-Claire, Qc

Est. Lic. No. 100107-A

Mallinckrodt Inc.

St. Louis, MO 63134 USA

MALLINCKRODT

CAUTION RADIOACTIVE MATERIAL

A450C0

R10/2000

SODIUM IODIDE I-131   THERAPEUTIC sodium iodide, i-131  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0019-N450 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM IODIDE I-131 (IODIDE I-131) SODIUM IODIDE I-131 1 mCi  in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM BISULFATE   EDETATE DISODIUM   SODIUM PHOSPHATE, DIBASIC ANHYDROUS

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0019-N450-F2 1  In 1 CAN contains a VIAL 1 5 mL In 1 VIAL This package is contained within the CAN (0019-N450-F2) 2 0019-N450-F4 1  In 1 CAN contains a VIAL 2 10 mL In 1 VIAL This package is contained within the CAN (0019-N450-F4) 3 0019-N450-F5 1  In 1 CAN contains a VIAL 3 15 mL In 1 VIAL This package is contained within the CAN (0019-N450-F5) 4 0019-N450-F6 1  In 1 CAN contains a VIAL 4 20 mL In 1 VIAL This package is contained within the CAN (0019-N450-F6) 5 0019-N450-F7 1  In 1 CAN contains a VIAL 5 25 mL In 1 VIAL This package is contained within the CAN (0019-N450-F7) 6 0019-N450-F8 1  In 1 CAN contains a VIAL 6 35 mL In 1 VIAL This package is contained within the CAN (0019-N450-F8) 7 0019-N450-F9 1  In 1 CAN contains a VIAL 7 50 mL In 1 VIAL This package is contained within the CAN (0019-N450-F9) 8 0019-N450-FC 1  In 1 CAN contains a VIAL 8 75 mL In 1 VIAL This package is contained within the CAN (0019-N450-FC) 9 0019-N450-FA 1  In 1 CAN contains a VIAL 9 100 mL In 1 VIAL This package is contained within the CAN (0019-N450-FA) 10 0019-N450-FB 1  In 1 CAN contains a VIAL 10 150 mL In 1 VIAL This package is contained within the CAN (0019-N450-FB)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA016515	08/22/2011

Labeler - Mallinckrodt, Inc. (047021092)

Establishment
Name	Address	ID/FEI	Operations
Mallinckrodt Inc.		557570652	manufacture, analysis

Establishment
Name	Address	ID/FEI	Operations
Nordion (Canada) Inc		201112088	api manufacture

Revised: 08/2011Mallinckrodt, Inc.

Keflex Suspension

Pronunciation: SEF-a-LEX-in
Generic Name: Cephalexin
Brand Name: Keflex

Keflex Suspension is used for:

Treating certain bacterial infections.

Keflex Suspension is a cephalosporin antibiotic. It works by interfering with the bacteria's cell wall formation. This weakens the cell wall, causing it to rupture, and kills the bacteria.

Do NOT use Keflex Suspension if:

• you are allergic to any ingredient in Keflex Suspension or to any other cephalosporin antibiotic (eg, cefuroxime)

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

Before using Keflex Suspension:

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

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


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


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


• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a penicillin (eg, amoxicillin) or other beta-lactam antibiotic (eg, imipenem)


• if you have stomach or bowel problems (eg, inflammation), blood clotting problems, kidney or liver problems, or poor nutrition

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

• Metformin because its actions and the risk of its side effects may be increased


• Probenecid because it may increase the actions and the risk of Keflex Suspension's side effects


• Anticoagulants (eg, warfarin) because the risk of side effects, such as bleeding, may be increased

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

How to use Keflex Suspension:

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

• Take Keflex Suspension by mouth with or without food.


• Shake well before each use.


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


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


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

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

Important safety information:

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


• Keflex Suspension may decrease the ability of your blood to clot. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


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


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


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


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


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


• Keflex Suspension may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Keflex Suspension.


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


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


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

Possible side effects of Keflex Suspension:

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

Diarrhea; dizziness; headache; indigestion; joint pain; stomach pain; tiredness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; confusion; dark urine; decreased urination; fever; hallucinations; red, swollen, or blistered skin; seizures; severe or bloody diarrhea; severe stomach pain or cramps; severe tiredness; unusual bruising or bleeding; unusual vaginal pain, odor, or discharge; yellowing of the eyes or skin.

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

See also: Keflex 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 blood in the urine; muscle spasm; nausea; seizures; severe diarrhea; vomiting.

Proper storage of Keflex Suspension:

Store Keflex Suspension in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Keflex Suspension out of the reach of children and away from pets. Throw away any unused medicine after 14 days.

General information:

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


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


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Keflex resources

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

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• Prostatitis
• Skin Infection
• Upper Respiratory Tract Infection