Brevinor Tablets

1. Name Of The Medicinal Product

Brevinor.

2. Qualitative And Quantitative Composition

Each tablet contains 0.5 milligrams norethisterone and 35 micrograms ethinylestradiol.

3. Pharmaceutical Form

Blue, flat, circular, bevel-edged tablet inscribed 'SEARLE' on one side and 'BX' on the other side.

4. Clinical Particulars

4.1 Therapeutic Indications

Brevinor is indicated for oral contraception, with the benefit of a low intake of oestrogen.

4.2 Posology And Method Of Administration

Oral Administration: The dosage of Brevinor for the initial cycle of therapy is 1 tablet taken at the same time each day from the first day of the menstrual cycle. For subsequent cycles, no tablets are taken for 7 days, then a new course is started of 1 tablet daily for the next 21 days. This sequence of 21 days on treatment, seven days off treatment is repeated for as long as contraception is required.

Patients unable to start taking Brevinor tablets on the first day of the menstrual cycle may start treatment on any day up to and including the 5th day of the menstrual cycle.

Patients starting on day 1 of their period will be protected at once. Those patients delaying therapy up to day 5 may not be protected immediately and it is recommended that another method of contraception is used for the first 7 days of tablet-taking. Suitable methods are condoms, caps plus spermicides and intra-uterine devices. The rhythm, temperature and cervical-mucus methods should not be relied upon.

Tablet omissions

Tablets must be taken daily in order to maintain adequate hormone levels and contraceptive efficacy.

If a tablet is missed within 12 hours of the correct dosage time then the missed tablet should be taken as soon as possible, even if this means taking 2 tablets on the same day, this will ensure that contraceptive protection is maintained. If one or more tablets are missed for more than 12 hours from the correct dosage time it is recommended that the patient takes the last missed tablet as soon as possible and then continues to take the rest of the tablets in the normal manner. In addition, it is recommended that extra contraceptive protection, such as a condom, is used for the next 7 days.

Patients who have missed one or more of the last 7 tablets in a pack should be advised to start the next pack of tablets as soon as the present one has finished (i.e. without the normal seven day gap between treatments). This reduces the risk of contraceptive failure resulting from tablets being missed close to a 7 day tablet free period.

Changing from another oral contraceptive

In order to ensure that contraception is maintained it is advised that the first dose of Brevinor tablets is taken on the day immediately after the patient has finished the previous pack of tablets.

Use after childbirth, miscarriage or abortion

Providing the patient is not breast feeding the first dose of Brevinor tablets should be taken on the 21st day after childbirth. This will ensure the patient is protected immediately. If there is any delay in taking the first dose, contraception may not be established until 7 days after the first tablet has been taken. In these circumstances patients should be advised that extra contraceptive methods will be necessary.

After a miscarriage or abortion patients can take the first dose of Brevinor tablets on the next day; in this way they will be protected immediately.

4.3 Contraindications

As with all combined progestogen/oestrogen oral contraceptives, the following conditions should be regarded as contra-indications:

i. History of confirmed venous thromboembolic disease (VTE), family history of idiopathic VTE and other known risk factors of VTE

ii. Thrombophlebitis, cerebrovascular disorders, coronary artery disease, myocardial infarction, angina, hyperlipidaemia or a history of these conditions.

iii. Acute or severe chronic liver disease, including liver tumours, Dubin-Johnson or Rotor syndrome.

iv. History during pregnancy of idiopathic jaundice, severe pruritus or pemphigoid gestationis.

v. Known or suspected breast or genital cancer.

vi. Known or suspected oestrogen-dependent neoplasia.

vii. Undiagnosed abnormal vaginal bleeding.

viii. A history of migraines classified as classical focal or crescendo.

ix. Pregnancy.

4.4 Special Warnings And Precautions For Use

Assessment of women prior to starting oral contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. Physical examination should be guided by this and by the contraindications (section 4.3) and warnings (section 4.4) for this product. The frequency and nature of these assessments should be based upon relevant guidelines and should be adapted to the individual woman, but should include measurement of blood pressure and, if judged appropriate by the clinician, breast, abdominal and pelvic examination including cervical cytology.

Women taking oral contraceptives require careful observation if they have or have had any of the following conditions: breast nodules; fibrocystic disease of the breast or an abnormal mammogram; uterine fibroids; a history of severe depressive states; varicose veins; sickle-cell anaemia; diabetes; hypertension; cardiovascular disease; migraine; epilepsy; asthma; otosclerosis; multiple sclerosis; porphyria; tetany; disturbed liver functions; gallstones; kidney disease; chloasma; any condition that is likely to worsen during pregnancy. The worsening or first appearance of any of these conditions may indicate that the oral contraceptive should be stopped. Discontinue treatment if there is a gradual or sudden, partial or complete loss of vision or any evidence of ocular changes, onset or aggravation of migraine or development of headache of a new kind, which is recurrent, persistent or severe.

Gastro-intestinal upsets, such as vomiting and diarrhoea, may interfere with the absorption of the tablets leading to a reduction in contraceptive efficacy. Patients should continue to take Brevinor, but they should also be encouraged to use another contraceptive method during the period of gastro-intestinal upset and for the next 7 days.

Progestogen oestrogen preparations should be used with caution in patients with a history of hepatic dysfunction or hypertension.

An increased risk of venous thromboembolic disease (VTE) associated with the use of oral contraceptives is well established but is smaller than that associated with pregnancy, which has been estimated at 60 cases per 100,000 pregnancies. Some epidemiological studies have reported a greater risk of VTE for women using combined oral contraceptives containing desogestrel or gestodene (the so-called 'third generation' pills) than for women using pills containing levonorgestrel or norethisterone (the so-called 'second generation' pills

The spontaneous incidence of VTE in healthy non-pregnant women (not taking any oral contraceptive) is about 5 cases per 100,000 per year. The incidence in users of second generation pills is about 15 per 100,000 women per year of use. The incidence in users of third generation pills is about 25 cases per 100,000 women per year of use; this excess incidence has not been satisfactorily explained by bias or confounding. The level of all of these risks of VTE increases with age and is likely to be further increased in women with other known risk factors for VTE such as obesity. . The excess risk of VTE is highest during the first year a woman ever uses a combined oral contraceptive.

Patients receiving oral contraceptives should be kept under regular surveillance, in view of the possibility of development of conditions such as thromboembolism.

The risk of coronary artery disease in women taking oral contraceptives is increased by the presence of other predisposing factors such as cigarette smoking, hypercholesterolaemia, obesity, diabetes, history of pre-eclamptic toxaemia and increasing age. After the age of thirty-five years, the patient and physician should carefully re-assess the risk/benefit ratio of using combined oral contraceptives as opposed to alternative methods of contraception.

Brevinor should be discontinued at least four weeks before, and for two weeks following, elective operations and during immobilisation. Patients undergoing injection treatment for varicose veins should not resume taking Brevinor until 3 months after the last injection.

Benign and malignant liver tumours have been associated with oral contraceptive use. The relationship between occurrence of liver tumours and use of female sex hormones is not known at present. These tumours may rupture causing intra-abdominal bleeding. If the patient presents with a mass or tenderness in the right upper quadrant or an acute abdomen, the possible presence of a tumour should be considered.

An increased risk of congenital abnormalities, including heart defects and limb defects, has been reported following the use of sex hormones, including oral contraceptives, in pregnancy. If the patient does not adhere to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and further use of oral contraceptives should be withheld until pregnancy has been ruled out. It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen. If pregnancy is confirmed the patient should be advised of the potential risks to the foetus and the advisability of continuing the pregnancy should be discussed in the light of these risks. It is advisable to discontinue Brevinor three months before a planned pregnancy.

The risk of arterial thrombosis associated with combined oral contraceptives increases with age, and this risk is aggravated by cigarette smoking. The use of combined oral contraceptives by women in the older age group, especially those who are cigarette smokers, should therefore be discouraged and alternative methods advised.

The use of this product in patients suffering from epilepsy, migraine, asthma or cardiac dysfunction may result in exacerbation of these disorders because of fluid retention. Caution should also be observed in patients who wear contact lenses.

Decreased glucose tolerance may occur in diabetic patients on this treatment, and their control must be carefully supervised.

The use of oral contraceptives has also been associated with a possible increased incidence of gall bladder disease.

Women with a history of oligomenorrhoea or secondary amenorrhoea or young women without regular cycles may have a tendency to remain anovulatory or to become amenorrhoeic after discontinuation of oral contraceptives. Women with these pre-existing problems should be advised of this possibility and encouraged to use other contraceptive methods.

Numerous epidemiological studies have been reported on the risks of ovarian, endometrial, cervical and breast cancer in women using combined oral contraceptives. The evidence is clear that combined oral contraceptives offer substantial protection against both ovarian and endometrial cancer.

An increased risk of cervical cancer in long-term users of combined oral contraceptives has been reported in some studies, but there continues to be controversy about the extent to which this is attributable to the confounding effects of sexual behaviour and other factors.

A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using combined oral contraceptives (COCs). The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in COC users, the biological effects of COCs or a combination of both. The additional breast cancers diagnosed in current users of COCs or in women who have used COCs in the last ten years are more likely to be localised to the breast than those in women who never used COCs.

Breast cancer is rare among women under 40 years of age whether or not they take COCs. Whilst this background risk increases with age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer (see bar chart).

The most important risk factor for breast cancer in COC users is the age women discontinue the COC; the older the age at stopping, the more breast cancers are diagnosed. Duration of use is less important and the excess risk gradually disappears during the course of the 10 years after stopping COC use such that by 10 years there appears to be no excess.

The possible increase in risk of breast cancer should be discussed with the user and weighed against the benefits of COCs taking into account the evidence that they offer substantial protection against the risk of developing certain other cancers (e.g. ovarian and endometrial cancer).

Estimated cumulative numbers of breast cancers per 10,000 women diagnosed in 5 years of use and up to 10 years after stopping COCs, compared with numbers of breast cancers diagnosed in 10,000 women who had never used COCs.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The herbal remedy St John's wort (Hypericum perforatum) should not be taken concomitantly with this medicine as this could potentially lead to a loss of contraceptive effect.

Some drugs may modify the metabolism of Brevinor reducing its effectiveness; these include certain sedatives, antibiotics, anti-epileptic and anti-arthritic drugs. During the time such agents are used concurrently, it is advised that mechanical contraceptives also be used.

The results of a large number of laboratory tests have been shown to be influenced by the use of oestrogen containing oral contraceptives, which may limit their diagnostic value. Among these are: biochemical markers of thyroid and liver function; plasma levels of carrier proteins, triglycerides, coagulation and fibrinolysis factors.

4.6 Pregnancy And Lactation

Contra-indicated in pregnancy.

Patients who are fully breast-feeding should not take Brevinor tablets since, in common with other combined oral contraceptives, the oestrogen component may reduce the amount of milk produced. In addition, active ingredients or their metabolites have been detected in the milk of mothers taking oral contraceptives. The effect of Brevinor on breast-fed infants has not been determined.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

As with all oral contraceptives, there may be slight nausea at first, weight gain or breast discomfort, which soon disappear.

Other side-effects known or suspected to occur with oral contraceptives include gastro-intestinal symptoms, changes in libido and appetite, headache, exacerbation of existing uterine fibroid disease, depression, and changes in carbohydrate, lipid and vitamin metabolism.

Spotting or bleeding may occur during the first few cycles. Usually menstrual bleeding becomes light and occasionally there may be no bleeding during the tablet-free days.

Hypertension, which is usually reversible on discontinuing treatment, has occurred in a small percentage of women taking oral contraceptives.

4.9 Overdose

Overdosage may be manifested by nausea, vomiting, breast enlargement and vaginal bleeding. There is no specific antidote and treatment should be symptomatic. Gastric lavage may be employed if the overdose is large and the patient is seen sufficiently early (within four hours).

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The mode of action of Brevinor is similar to that of other progestogen/oestrogen oral contraceptives and includes the inhibition of ovulation, the thickening of cervical mucus so as to constitute a barrier to sperm and the rendering of the endometrium unreceptive to implantation. Such activity is exerted through a combined effect on one or more of the following: hypothalamus, anterior pituitary, ovary, endometrium and cervical mucus.

5.2 Pharmacokinetic Properties

Norethisterone is rapidly and completely absorbed after oral administration, peak plasma concentrations occurring in the majority of subjects between 1 and 3 hours. Due to first-pass metabolism, blood levels after oral administration are 60% of those after i.v. administration. The half life of elimination varies from 5 to 12 hours, with a mean of 7.6 hours. Norethisterone is metabolised mainly in the liver. Approximately 60% of the administered dose is excreted as metabolites in urine and faeces.

Ethinylestradiol is rapidly and well absorbed from the gastro-intestinal tract but is subject to some first-pass metabolism in the gut-wall. Compared to many other oestrogens it is only slowly metabolised in the liver. Excretion is via the kidneys with some appearing also in the faeces.

5.3 Preclinical Safety Data

The toxicity of norethisterone is very low. Reports of teratogenic effects in animals are uncommon. No carcinogenic effects have been found even in long-term studies.

Long-term continuous administration of oestrogens in some animals increases the frequency of carcinoma of the breast, cervix, vagina and liver.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Brevinor tablets contain:

Maize starch, polyvidone, magnesium stearate, lactose and E132.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

The shelf life of Brevinor tablets is 5 years.

6.4 Special Precautions For Storage

Store in a dry place, below 25^oC, away from direct sunlight.

6.5 Nature And Contents Of Container

Brevinor tablets are supplied in pvc/foil blister packs of 21 and 63 tablets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Pharmacia Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ, UK

8. Marketing Authorisation Number(S)

PL 00032/0398

9. Date Of First Authorisation/Renewal Of The Authorisation

27 June 2002

10. Date Of Revision Of The Text

June 2007

terbinafine topical

Generic Name: terbinafine topical (ter BIN a feen TOP i kal)

Brand names: Athlete's Foot Cream, LamISIL AT, LamISIL AT Athletes Foot, LamISIL AT Jock Itch, LamISIL Topical, Desenex Maximum

What is terbinafine topical?

Terbinafine is an antifungal medication. Terbinafine topical prevents fungus from growing on the skin.

Terbinafine topical (for the skin) is used to treat skin infections such as athlete's foot, jock itch, and ringworm infections.

Terbinafine topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about terbinafine topical?

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to.

Avoid getting this medication in your mouth or eyes.

What should I discuss with my healthcare provider before using terbinafine topical?

You should not use this medication if you are allergic to it. It is not known whether terbinafine topical will be harmful to an unborn baby. Do not use terbinafine topical without first talking to your doctor if you are pregnant. It is not known whether terbinafine topical 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.

How should I use terbinafine topical?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the medication as directed.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to.

Store terbinafine topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not apply 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 terbinafine topical is not likely to cause life-threatening symptoms.

What should I avoid while using terbinafine topical?

Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water.

Avoid using other medications on the areas you treat with terbinafine topical unless your doctor has told you to.

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Terbinafine topical side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using terbinafine topical and call your doctor at once if you have a serious side effect such as severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

Less serious side effects are more likely, and you may have none at all.

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.

Terbinafine topical Dosing Information

Usual Adult Dose for Tinea Corporis:

Cream, gel, spray: Apply to the affected area once a day.

Usual Adult Dose for Tinea Cruris:

Cream, gel, spray: Apply to the affected area once a day.

Usual Adult Dose for Tinea Pedis:

Cream, spray: Apply to the affected area twice a day.
Gel: Apply to the affected area once a day.

Usual Adult Dose for Tinea Versicolor:

Solution: Apply to the affected area twice a day.

Usual Pediatric Dose for Tinea Corporis:

12 years or older:
Cream, gel, spray: Apply to the affected area once a day.

Usual Pediatric Dose for Tinea Cruris:

12 years or older:
Cream, gel, spray: Apply to the affected area once a day.

Usual Pediatric Dose for Tinea Pedis:

12 years or older:
Cream, spray: Apply to the affected area twice a day.
Gel: Apply to the affected area once a day.

What other drugs will affect terbinafine topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied terbinafine topical. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More terbinafine topical resources

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

• Lamisil AT Prescribing Information (FDA)


• Lamisil AT Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Lamisil AT Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Lamisil AT Jock Itch Prescribing Information (FDA)

Compare terbinafine topical with other medications

• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Where can I get more information?

• Your pharmacist has additional information about terbinafine topical written for health professionals that you may read.

Thalomid

Pronunciation: tha-LID-oh-mide
Generic Name: Thalidomide
Brand Name: Thalomid

Thalomid may cause severe birth defects or death of the fetus if used during pregnancy.

Women who are able to become pregnant and who take Thalomid:

• must not become pregnant;


• must either avoid sexual contact with men or use at least 2 forms of effective birth control for 4 weeks before starting Thalomid, while taking Thalomid, and for 4 weeks after stopping Thalomid;


• must have a negative pregnancy test within 24 hours before starting Thalomid; and


• must have a pregnancy test every week for the first 4 weeks after starting Thalomid and then every 2 to 4 weeks thereafter while taking Thalomid.

Women who take Thalomid and experience abnormal menstrual bleeding, miss their menstrual period, become pregnant, or suspect for any reason they may be pregnant must stop taking it and contact their doctor immediately.

Men who take Thalomid:

• must either avoid sexual contact with women who are pregnant or could become pregnant while taking Thalomid and for 4 weeks after stopping Thalomid; OR


• must use a latex condom during sexual contact with women who are pregnant or could become pregnant for as long as they are taking Thalomid and for 4 weeks after stopping Thalomid, even if they have had a successful vasectomy.

Men who take Thalomid and have unprotected sexual contact with a woman who is pregnant or may become pregnant, or who think for any reason that their sexual partner may be pregnant should contact their doctor immediately.

All patients who take Thalomid:

• Thalomid passes into semen. Female partners of men taking Thalomid should call their doctor if they become pregnant.


• All patients must receive and understand all oral and written warnings about the risks of using Thalomid.


• All patients must be able to follow the instructions for using Thalomid and for using effective birth control methods if they are sexually active.

Use of Thalomid in certain cancer patients increases their risk for blood clots in the arms, legs, or lungs. The risk is increased when it is used with certain other medicines, including dexamethasone. Contact your doctor right away if you develop shortness of breath, chest pain, calf pain or tenderness, or swelling of an arm or leg.

Thalomid is used for:

Treating and preventing skin inflammation in patients who have moderate to severe erythema nodosum leprosum (ENL, leprosy). It is used with other medicines if the patient also has moderate to severe nerve inflammation due to ENL. It is also used with dexamethasone to treat patients who have a certain type of cancer (multiple myeloma).

Thalomid is an immunomodulatory agent. It works on the immune system to decrease certain substances that cause skin inflammation in patients who have ENL. In cancer patients, it appears to increase certain natural substances that help to kill cancer cells.

Do NOT use Thalomid if:

• you are allergic to any ingredient in Thalomid


• you are pregnant, planning to become pregnant, could become pregnant, or if you become pregnant during treatment with Thalomid


• you are taking sodium oxybate (GHB)

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

Before using Thalomid:

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

• if you 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 HIV infection, unusual growth or tumors, cancer, low white blood cell count, or if you are on chemotherapy


• if you have a history of irregular menstrual periods, slow heartbeat, numbness or tingling in your hands or feet, blood clots, or seizures or epilepsy

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

• Barbiturates (eg, phenobarbital), phenothiazines (eg, chlorpromazine), reserpine, or sodium oxybate (GHB) because the risk of severe drowsiness may be increased

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

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

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


• Thalomid can only be prescribed and dispensed through a special program. Make sure you understand all warnings and instructions for using Thalomid. Ask your doctor or pharmacist if you have any questions about this program or how to use Thalomid.


• Take Thalomid with water at least 1 hour after eating.


• If you are taking 1 dose daily, take it at bedtime, unless your doctor tells you otherwise.


• Do not open the capsules or handle Thalomid more than necessary. Keep Thalomid in the blister pack until just before you are ready to take it. If you touch a capsule that has been opened or get the powder on your skin, wash the area with soap and water right away.


• Women who are able to become pregnant (including those who have started menopause within the last 24 months), must use at least 2 methods of effective birth control while taking Thalomid, unless they are not sexually active. These birth control methods must be used for at least 4 weeks before starting Thalomid, while taking Thalomid, and for 4 weeks after stopping Thalomid. Talk with your doctor about which methods of effective birth control may be appropriate for you.


• Men who take Thalomid must use a latex condom during any sexual contact with a woman who is pregnant or could become pregnant for as long as they are taking Thalomid and for 4 weeks after stopping Thalomid. This includes men who have had a vasectomy.


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


• If you miss a dose of Thalomid and you are taking 1 dose daily at bedtime, skip the missed dose and go back to your regular dosing schedule. Do not take the missed dose in the morning. Do not take 2 doses at once.

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

Important safety information:

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


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Thalomid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


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


• Hormonal birth control (eg, birth control pills) may not work as well when taken with antibiotics or certain other medicines. Inform your doctor if you are taking antibiotics (eg, penicillin, amoxicillin, ampicillin), carbamazepine, an HIV-protease inhibitor (eg, ritonavir), griseofulvin, modafinil, phenytoin, rifabutin, or St. John's wort. Women requiring treatment with any of these medicines MUST use two other forms of birth control or abstain from sexual intercourse while using Thalomid.


• Thalomid is found in semen. Men who take Thalomid must always use a latex condom during sexual contact with women who are pregnant or may become pregnant.


• Do not donate blood, semen, or sperm while taking Thalomid or within 4 weeks after stopping Thalomid.


• Thalomid may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Thalomid may cause nerve damage. Symptoms may develop during treatment or after treatment is stopped. Symptoms of nerve damage may resolve slowly over time but may be permanent in some cases. Contact your doctor right away if you develop symptoms of numbness, tingling, burning sensation, or pain in the hands, arms, legs, or feet.


• Thalomid may increase the risk of blood clots in certain patients. Call your doctor at once if you notice shortness of breath; chest pain; or pain, tenderness, or swelling in an arm or leg.


• Lab tests, including pregnancy tests, complete blood cell counts, and nerve tests, may be performed while you use Thalomid. HIV-positive patients will need to have viral load measured regularly. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


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


• Thalomid should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Use of Thalomid during pregnancy has resulted in severe birth defects and death of the fetus. If you think you may be pregnant, miss your menstrual period, experience unusual menstrual bleeding, or stop using birth control, contact your doctor at once. If you become pregnant while using Thalomid, consult an obstetrician/gynecologist experienced in reproductive toxicity. It is unknown if Thalomid is found in breast milk. Do not breast-feed while taking Thalomid.

Possible side effects of Thalomid:

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:

Constipation; diarrhea; dizziness; drowsiness; headache; nausea; trouble sleeping; weakness.

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); burning, numbness, pain, or tingling of your hands, feet, arms, legs, or around the mouth or lips; calf pain or tenderness; chest pain; dark urine; decreased sexual ability; eye pain or vision changes; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hearing changes or hearing loss; mood or mental changes (eg, depression, suicidal thoughts or actions); mouth sores or irritation; neck pain or stiffness; pain or swelling in the arms or legs; red, swollen, blistered, or peeling skin; ringing in the ears or hearing changes; seizures; severe tiredness or weakness; shortness of breath; stiff neck; tremor; unusual bruising or bleeding; unusual 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: Thalomid side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Thalomid:

Store Thalomid at 77 degrees F (25 degrees C) in the original packaging. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. Keep Thalomid out of the reach of children and away from pets.

General information:

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


• Thalomid 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 Thalomid. 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 Thalomid resources

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

• Thalomid Prescribing Information (FDA)


• Thalomid Consumer Overview


• Thalomid Monograph (AHFS DI)


• Thalomid Advanced Consumer (Micromedex) - Includes Dosage Information


• Thalidomide Professional Patient Advice (Wolters Kluwer)

Compare Thalomid with other medications

• Leprosy, Erythema Nodosum Leprosum
• Multiple Myeloma

Liquid Polibar Plus oral and rectal

Generic Name: barium sulfate (oral and rectal) (BER ee um SUL fate)

Brand Names: Anatrast, Bar-Test, Baricon, Baro-Cat, Barosperse, Bear-E-Yum GI, CheeTah, CheeTah Butterscotch, CheeTah Chocolaty-Fudge, CheeTah Orange, CheeTah Raspberry, Digibar 190, E-Z AC, E-Z Disk, E-Z Dose Kit with Polibar Plus, E-Z Paste, E-Z-Cat, E-Z-Cat Dry, E-Z-HD, E-Z-Paque, Enecat, Eneset 2, Enhancer, Entero VU, Entero-H, Entrobar, Esopho-Cat, Intropaste, Liqui-Coat HD, Liquid Barosperse, Liquid E-Z Paque, Liquid Polibar, Liquid Polibar Plus, Maxibar, Medebar Plus, Medebar Super 250, Polibar ACB, Readi-Cat, Readi-Cat 2, Scan C, Sitzmarks, Smoothie Readi-Cat 2, Sol-O-Pake, Tagitol V, Tonojug, Tonopaque, Varibar Honey, Varibar Nectar, Varibar Pudding, Varibar Thin, Varibar Thin Honey, Volumen

What is barium sulfate?

Barium sulfate is in a group of drugs called contrast agents. Barium sulfate works by coating the inside of your esophagus, stomach, or intestines which allows them to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Barium sulfate is used to help diagnose certain disorders of the esophagus, stomach, or intestines.

Barium sulfate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about barium sulfate?

You should not use this medication if you are allergic to barium sulfate. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

Before you use barium sulfate, tell your doctor if you have any allergies, or if you have asthma, cystic fibrosis, heart disease or high blood pressure, rectal cancer, a colostomy, a blockage in your stomach or intestines, a condition called pseudotumor cerebri, or if you have recently had a rectal biopsy or surgery on your esophagus, stomach, or intestines.

Tell your doctor if you are pregnant or breast-feeding before your medical test.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.

Serious side effects of barium sulfate may include severe stomach pain, sweating, ringing in your ears, pale skin, weakness, or severe cramping, diarrhea, or constipation

What should I discuss with my health care provider before using barium sulfate?

You should not use barium sulfate if you are allergic to it. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

To make sure you can safely use barium sulfate, tell your doctor if you have any of these other conditions:

• 
  

  asthma, eczema, or allergies;

  
  


• 
  

  a blockage in your stomach or intestines;

  
  


• 
  

  cystic fibrosis;

  
  


• 
  

  a colostomy;

  
  


• 
  

  rectal cancer;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  Hirschsprung's disease (a disorder of the intestines);

  
  


• 
  

  a condition called pseudotumor cerebri (high pressure inside the skull that may cause headaches, vision loss, or other symptoms);

  
  


• 
  

  a recent history of surgery on your esophagus, stomach, or intestines;

  
  


• 
  

  a history of perforation (a hole or tear) in your esophagus, stomach, or intestines;

  
  


• 
  

  if you have recently had a rectal biopsy;

  
  


• 
  

  if you have ever choked on food by accidentally inhaling it into your lungs;

  
  


• 
  

  if you are allergic to simethicone (Gas-X, Phazyme, and others); or

  
  


• 
  

  if you are allergic to latex rubber.

  
  

It is not known whether barium sulfate will harm an unborn baby, but the radiation used in x-rays and CT scans may be harmful. Before your medical test, tell your doctor if you are pregnant. Barium sulfate may pass into breast milk and could harm a nursing baby. Before your medical test, tell your doctor if you are breast-feeding a baby.

How should I use barium sulfate?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Barium sulfate comes in tablets, paste, cream, or liquid forms.

In some cases, barium sulfate is taken by mouth. The liquid form may also be used as a rectal enema.

You may need to begin using this medication at home a day before your medical test. Follow your doctor's instructions about how much of the medication to use and how often.

If you are receiving barium sulfate as a rectal enema, a healthcare professional will give you the medication at the clinic or hospital where your testing will take place.

Do not crush, chew, or break a barium sulfate tablet. Swallow the pill whole.

Dissolve the barium sulfate powder in a small amount of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

If you receive the medication as a liquid to take by mouth, shake the liquid well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.

Store at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

If you are using barium sulfate at home, call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe stomach pain, ongoing diarrhea, confusion, or weakness.

What should I avoid before or after using barium sulfate?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Barium sulfate 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  severe stomach pain;

  
  


• 
  

  severe cramping, diarrhea, or constipation;

  
  


• 
  

  sweating;

  
  


• 
  

  ringing in your ears;

  
  


• 
  

  confusion, fast heart rate; or

  
  


• 
  

  pale skin, weakness.

  
  

Less serious side effects may include:

• 
  

  mild stomach cramps;

  
  


• 
  

  nausea, vomiting;

  
  


• 
  

  loose stools or mild constipation.

  
  

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 barium sulfate?

There may be other drugs that can interact with barium sulfate. 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.

More Liquid Polibar Plus resources

• Liquid Polibar Plus Side Effects (in more detail)
• Liquid Polibar Plus Use in Pregnancy & Breastfeeding
• 0 Reviews for Liquid Polibar Plus - Add your own review/rating

Compare Liquid Polibar Plus with other medications

• Computed Tomography

Where can I get more information?

• Your doctor or pharmacist can provide more information about barium sulfate.

See also: Liquid Polibar Plus side effects (in more detail)

Guaifenesin Granules

Pronunciation: gwye-FEN-eh-sin
Generic Name: Guaifenesin
Brand Name: Examples include Mucinex Children's and Mucinex Junior Strength

Guaifenesin Granules are used for:

Relieving symptoms of cough and mucus in the chest due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Guaifenesin Granules are an expectorant. It works by thinning mucus (phlegm) in the lungs and making it less sticky and easier to cough up. This reduces chest congestion by making coughs more productive.

Do NOT use Guaifenesin Granules if:

• you are allergic to any ingredient in Guaifenesin Granules

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

Before using Guaifenesin Granules:

Some medical conditions may interact with Guaifenesin Granules. 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 persistent cough that occurs with smoking, asthma, chronic bronchitis, or emphysema, or if your cough occurs with large amounts of mucus


• if you have phenylketonuria

Some MEDICINES MAY INTERACT with Guaifenesin Granules. Tell your health care provider if you are taking any other medicines. However, no specific interactions with Guaifenesin Granules are known at this time.

Ask your health care provider if Guaifenesin Granules 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 Guaifenesin Granules:

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

• Take Guaifenesin Granules by mouth with or without food.


• Drinking extra fluids while you are taking Guaifenesin Granules are recommended. Check with your doctor for instructions.


• Empty the entire contents of the packet onto the tongue and swallow. For best taste, do not chew before swallowing.


• If you miss a dose of Guaifenesin Granules and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. 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 Guaifenesin Granules.

Important safety information:

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


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• Different brands of Guaifenesin Granules may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Guaifenesin Granules while you are pregnant. It is not known if Guaifenesin Granules are found in breast milk. If you are or will be breast-feeding while you use Guaifenesin Granules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Guaifenesin Granules:

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:

Nausea; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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: Guaifenesin side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Guaifenesin Granules:

Store Guaifenesin Granules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Guaifenesin Granules out of the reach of children and away from pets.

General information:

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


• Guaifenesin Granules are 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 Guaifenesin Granules. 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 Guaifenesin resources

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

Compare Guaifenesin with other medications

• Bronchitis
• Cough
• Fibromyalgia

Terra-Cortril

Dosage Form: Ophthalmic Suspension

Terra-Cortril Description

Terra-Cortril suspension combines the antibiotic, oxytetracycline HCl (C22H24N2O9•HCl) and the adrenocorticoid, hydrocortisone acetate (C23H32O6). Each ml of Terra-Cortril contains Terramycin (oxytetracycline HCl) equivalent to 5 mg of oxytetracycline, and 15 mg of Cortril (hydrocortisone acetate) incorporated in mineral oil with aluminum tristearate.

For Ophthalmic Use Only.

Terra-Cortril - Clinical Pharmacology

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.

The anti-infective component in the combination is included to provide action against specific organisms susceptible to it.

Terramycin is considered active against the following microorganisms:

• Rickettsiae (Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers),


• Mycoplasma pneumoniae (PPLO, Eaton Agent),


• Agents of psittacosis and ornithosis,


• Agents of lymphogranuloma venereum and granuloma inguinale,


• The spirochetal agent of relapsing fever (Borrelia recurrentis).

The following gram-negative microorganisms:

• Haemophilus ducreyi (chancroid),


• Pasteurella pestis and Pasteurella tularensis,


• Bartonella bacilliformis,


• Bacteroides species,


• Vibrio comma and Vibrio fetus,


• Brucella species (in conjunction with streptomycin).

Because many strains of the following groups of microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended.

Oxytetracycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:

• Escherichia coli,


• Enterobacter aerogenes (formerly Aerobacter aerogenes),


• Shigella species,


• Mima species and Herellea species,


• Haemophilus influenzae (respiratory infections),


• Klebsiella species (respiratory and urinary infections).

Oxytetracycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:

Streptococcus species:

Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Streptococcus faecalis have been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used for streptococcal disease unless the organism has been demonstrated to be sensitive.

For upper respiratory infections due to Group A beta-hemolytic streptococci, pencillin is the usual drug of choice, including prophylaxis of rheumatic fever.

Diplococcus pneumoniae,

Staphylococcus aureus, skin and soft tissue infections. Oxytetracycline is not the drug of choice in the treatment of any type of staphylococcal infections.

When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of infections due to:

• Neisseria gonorrhoeae,


• Treponema pallidum and Treponema pertenue (syphilis and yaws),


• Listeria monocytogenes,


• Clostridium species,


• Bacillus anthracis,


• Fusobacterium fusiforme (Vincent's infection),


• Actinomyces species.

Tetracyclines are indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence.

Inclusion conjunctivitis may be treated with oral tetracyclines or with a combination of oral and topical agents.

When a decision to administer both a corticoid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when both types of drug are in the same formulation and, particularly, that the correct volume of drug is delivered and retained.

The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.

Indications and Usage for Terra-Cortril

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical radiation, thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:

• Staphylococcus aureus


• Streptococci, including Streptococcus pneumoniae


• Escherichia coli


• Neisseria species

The product does not provide adequate coverage against:

• Haemophilus influenzae


• Klebsiella/Enterobacter species


• Pseudomonas aeruginosa


• Serratia marcescens

Contraindications

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication. (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)

The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.

Warnings

Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.

Employment of steroid medication in the treatment of herpes simplex requires great caution.

Precautions

The initial prescription and renewal of the medication order beyond 20 milliliters should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing.

Adverse Reactions

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the steroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection

The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.

Secondary bacterial ocular infection following suppression of host responses also occurs.

Terra-Cortril Dosage and Administration

Instill 1 or 2 drops of Terra-Cortril Ophthalmic Suspension into the affected eye three times daily.

Not more than 20 milliliters should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in "Precautions" above.

How is Terra-Cortril Supplied

Terra-Cortril Ophthalmic Suspension (NDC 0049-0670-48) is supplied in 5 ml vials with separate sterile dropper.

LAB-0194-2.0

TERRA-CORTRIL  oxytetracycline hydrochloride and hydrocortisone acetate  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0049-0670 Route of Administration OPHTHALMIC DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength oxytetracycline hydrochloride (oxytetracycline) Active 5 MILLIGRAM  In 1 MILLILITER hydrocortisone acetate (hydrocortisone) Active 15 MILLIGRAM  In 1 MILLILITER mineral oil Inactive   aluminum tristearate Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0049-0670-48 5 mL (MILLILITER) In 1 VIAL None

Revised: 04/2006Roerig

More Terra-Cortril resources

• Terra-Cortril Drug Interactions
• Terra-Cortril Support Group
• 0 Reviews · Be the first to review/rate this drug

Altacaine Drops

Pronunciation: TET-ra-kane
Generic Name: Tetracaine
Brand Name: Examples include Altacaine and Opticaine

Altacaine Drops are used for:

Numbing the eye during certain procedures.

Altacaine Drops are an anesthetic. It works by blocking nerve impulses, which results in loss of feeling.

Do NOT use Altacaine Drops if:

• you are allergic to any ingredient in Altacaine Drops

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

Before using Altacaine Drops:

Some medical conditions may interact with Altacaine Drops. 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

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

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

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

• Altacaine Drops are administered at your doctor's office, hospital, or clinic. Ask your doctor or pharmacist any questions that you may have about Altacaine Drops.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.


• Do not touch or rub the eye until the effect of the medicine has worn off. Your doctor may instruct you to wear an eye patch to prevent you or anything else from touching your eye.


• If you miss a dose of Altacaine Drops, check with your doctor.

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

Important safety information:

• Altacaine Drops may be harmful if swallowed. If you may have taken Altacaine Drops by mouth, contact your local poison control center or emergency room immediately.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Altacaine Drops, discuss with your doctor the benefits and risks of using Altacaine Drops during pregnancy. If you are or will be breast-feeding while you are using Altacaine Drops, check with your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, Altacaine Drops may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Altacaine Drops stops working well. Do not take more than prescribed.

Possible side effects of Altacaine Drops:

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:

Temporary burning, stinging, or redness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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: Altacaine side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Altacaine Drops:

Store Altacaine Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, light, and moisture. Keep Altacaine Drops out of the reach of children and away from pets.

General information:

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


• Altacaine Drops are 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 Altacaine Drops. 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 Altacaine resources

• Altacaine Side Effects (in more detail)
• Altacaine Use in Pregnancy & Breastfeeding
• Altacaine Support Group
• 0 Reviews · Be the first to review/rate this drug