Gelnique Gel

Pronunciation: OX-i-BUE-ti-nin
Generic Name: Oxybutynin
Brand Name: Gelnique

Gelnique Gel is used for:

Treating overactive bladder with symptoms of urgency, frequency, or leakage. It may also be used for other conditions as determined by your doctor.

Gelnique Gel is an anticholinergic. It works by relaxing muscles in the bladder.

Do NOT use Gelnique Gel if:

• you are allergic to any ingredient in Gelnique Gel


• you have bladder blockage or are unable to urinate


• you have certain stomach or bowel problems (eg, blockage, decreased muscle movement)


• you have uncontrolled narrow-angle glaucoma


• you are taking a solid oral potassium product (eg, tablet)

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

Before using Gelnique Gel:

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

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


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


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


• if you have trouble urinating or have very poor health


• if you have a history of heart problems (eg, heart failure, fast or irregular heartbeat), high blood pressure, nervous system problems, liver or kidney problems, myasthenia gravis, an enlarged prostate, an overactive thyroid, esophagus problems (eg, reflux disease, inflammation, narrowing), stomach or bowel problems (eg, colitis, inflammation, constipation), or a hiatal hernia


• if you have a history of glaucoma or increased pressure in the eyes, or if you are at risk of glaucoma (eg, family history of glaucoma)

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

• Bisphosphonates (eg, alendronate) because the risk of irritation of the esophagus may be increased


• Disulfiram because a reaction that includes flushing, headache, nausea, vomiting, fast or irregular heartbeat, shortness of breath, or severe dizziness may occur


• Other anticholinergic medicines (eg, scopolamine), azole antifungals (eg, ketoconazole), or macrolide antibiotics (eg, erythromycin) because they may increase the risk of Gelnique Gel's side effects


• Solid oral potassium products (eg, tablets) because the risk of stomach or bowel irritation may be increased by Gelnique Gel


• Phenothiazines (eg, chlorpromazine) because their effectiveness may be decreased by Gelnique Gel and they may increase the risk of Gelnique Gel's side effects

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

How to use Gelnique Gel:

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

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


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


• Apply Gelnique Gel to dry, undamaged skin on the stomach, upper arms, shoulders, or thighs. If you apply Gelnique Gel to the stomach, avoid the area around the belly button.


• Do not use the same application site 2 days in a row. Do not apply Gelnique Gel to other areas of the body.


• Do not apply Gelnique Gel to skin with an open sore or rash, or to an area that has been recently shaved.


• Do not apply Gelnique Gel to areas of the skin that have been treated with oils, lotions, or powders. However, you may use Gelnique Gel with sunscreen.


• Do not open the packet until just before use.


• Wash your hands and the application site with mild soap and water before you apply Gelnique Gel. Allow the area to dry completely.


• Squeeze the entire contents of the packet into the palm of your hand or directly onto the application site. Gently rub Gelnique Gel into your skin until it dries. Do not continue to rub after it dries.


• Wash your hands immediately after you apply Gelnique Gel.


• Do not bathe, swim, shower, exercise, or get the application site wet for at least 1 hour after using Gelnique Gel.


• Be careful not to get Gelnique Gel on another person. If another person may come into contact with the application site, cover the area with clothing after the medicine dries.


• Discard used packets appropriately out of the reach of children and away from pets.


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


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

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

Important safety information:

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


• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Gelnique Gel; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Gelnique Gel may cause decreased sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur. Contact your doctor if you have been exposed to high temperatures and you develop fever; flushing; hot, dry skin; severe or persistent headache; dizziness; sudden fatigue; fast heartbeat; seizures; or fainting.


• Gelnique Gel may cause dry mouth. To help relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute. Ask your doctor or pharmacist if you have any questions.


• A serious side effect called angioedema has been reported with the use of oral dosage forms of Gelnique Gel (eg, tablets). Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.


• Gelnique Gel is flammable. Do not smoke while using Gelnique Gel. Do not store or use near an open flame.


• If another person comes into contact with Gelnique Gel, they should wash it off right away with mild soap and water.


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


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


• Gelnique Gel should be used with extreme caution in CHILDREN; safety and effectiveness in children has not been confirmed.


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

Possible side effects of Gelnique Gel:

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:

Blurred vision; constipation; dizziness; drowsiness; dry mouth; headache; mild redness, irritation, or itching at the application site.

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

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); blisters, rash, pain, or loss of feeling at the application site; confusion; difficult or painful urination; fast or irregular heartbeat; fever; hallucinations; mental or mood changes (eg, agitation); seizures; severe or persistent redness, irritation, or itching at the application site; swelling of the hands, ankles, or feet; vision problems.

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: Gelnique 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; delirium; fever; flushing; hallucinations; inability to urinate; irregular heartbeat; paralysis; seizures; severe or persistent dizziness or headache; tremor; trouble breathing; vomiting.

Proper storage of Gelnique Gel:

Store Gelnique Gel at room temperature, 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Gelnique Gel out of the reach of children and away from pets.

General information:

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


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


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Gelnique resources

• Gelnique Side Effects (in more detail)
• Gelnique Use in Pregnancy & Breastfeeding
• Gelnique Drug Interactions
• Gelnique Support Group
• 1 Review for Gelnique - Add your own review/rating

Compare Gelnique with other medications

• Dysuria
• Overactive Bladder
• Urinary Incontinence

Pollen Injection

ALLERGENIC EXTRACT INSTRUCTIONS FOR USE AND DOSAGE SCHEDULE

Warnings

This allergenic product is intended for use by physicians who are experienced in the administration of allergenic extracts, and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist.

This allergenic extract is not directly interchangeable with other allergenic extracts. The initial dose must be based on skin testing as described in the dosage and administration section of this insert. Patients being switched from other types of extracts, such as alum precipitated extracts, should be started as though they were coming under treatment for the first time. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician's office if reaction symptoms occur. As with all allergenic extracts, severe systemic reactions may occur. In certain individuals these systemic reactions may occur. In certain individuals these reactions may be life threatening. Patients should be observed for at least 20 minutes following treatment, and emergency measures as well as personnel trained in their use should be immediately available in the event of a life threatening reaction.

This product should not be injected intravenously (see Dosage and Administration). Refer also to the Warnings, Precautions, Adverse Reactions and Overdosage sections below.

Pollen Injection Description

Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.

Pollen Injection - Clinical Pharmacology

Positive skin tests with allergenic extract are the result of histamine release from mast cells sensitized with allergen specific IgE. The exact mechanisms by which immunotherapy relieves symptoms of allergy are still under investigation. Elevations in allergen-specific IgG antibodies and an increase in the activity of T suppressor lymphocytes appear to be some of the immunologic changes that occur from hyposensitization.1,2,3

Indications and Usage for Pollen Injection

Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease.4,5,6

Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms.7-12

Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.

Contraindications

Allergenic extract should not be administered to a non-allergic person. However, there are no absolute contraindications to the use of allergenic extract for treatment in appropriate individuals. Relative contraindications include: EXTREME SENSITIVITY TO AN ALLERGEN - Determined from the allergic history, or from previous anaphylaxis following skin testing or subcutaneous injection; AUTOIMMUNE DISEASE - Individuals with autoimmune disease may be at risk, due to the possibility of routine immunizations exacerbating symptoms of the underlying disease; PREGNANCY - In limited controlled studies of women receiving allergenic extract during conception and throughout all trimesters of pregnancy, no evidence was found that extract is harmful to the fetus or mother. However, because of the known pharmacologic action of histamine on uterine muscle, any treatment that might result in the release of significant amounts of this mediator should be avoided if possible13. See Precaution #4; MYOCARDIAL INFARCTION - Patients who have experienced a recent myocardial infarction may not be able to tolerate immunotherapy. As in all of the above circumstances, the benefit to risk ration must be carefully evaluated; BLEEDING DIATHESIS - Patients with a bleeding tendency should not be tested or treated with allergenic extract, unless the physician responsible believes that such procedures are safe to perform.

Allergenic extract should be temporarily withheld from patients if any of the following conditions exist: (1) severe symptoms of hay fever and/or asthma; (2) infection or flu accompanied by fever; and (3) exposure to excessive amounts of clinically relevant allergens prior to skin testing or immunotherapy.

Warnings

The only approved method for determining hypersensitivity to Allermed Laboratories Allergenic Extracts is by diagnostic skin testing (See DOSAGE AND ADMINISTRATION — DIAGNOSIS).

Physicians who administer allergenic extract should have emergency medication and equipment available to treat anaphylaxis14. See Precautions, Adverse Reactions and Overdosage below.

To reduce the risk of anaphylaxis, the following measures must be observed:

1. Concentrated extract must be diluted before use for intradermal skin testing and for beginning immunotherapy. It should never be injected intravenously during testing or treatment procedures.


2. Patients who are highly sensitive, determined from clinical findings and test results, may require that treatment start with a very weak concentration of extract, such as 1:10,000,000 v/v.


3. The dosage of fresh (new) extract given to a patient receiving maintenance injections must be reduced to one-fourth the amount given from the previous (old) lot (See Immunotherapy, last paragraph).


4. Patients who are transferred to standardized extract after previous treatment with unstandardized extract must be skin tested with serial dilutions, starting with a 1:100,000 v/v dilution of the standardized extract, to determine a safe, non-reacting starting dose.


5. Patients who are transferred to this extract after treatment with alum precipitated or other modified extract must re-start injections with the beginning recommended dose of this extract.

Precautions

1. Extract should be stored at 2°C to 8°C since higher temperatures may adversely affect the stability of the product. Do not freeze.


2. After the needle is inserted subcutaneously, the plunger should be withdrawn slightly to check for the presence of blood in the syringe. If blood is observed, a new injection should be prepared and given at another site, observing the same precautions.


3. Treatment with beta-blocking drugs may make patients refractory to the usual dose of epinephrine, in the event epinephrine is required to control an adverse allergic reaction.


4. PREGNANCY CATEGORY C. Allergenic extract. Animal reproduction studies have not been conducted with allergenic extract. It is also not known whether allergenic extract can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Allergenic extract should be given to a pregnant woman only if clearly needed.


5. PATIENT INSTRUCTIONS: Patients should be instructed to remain in the physician's office for at least 20 minutes after skin testing and after each treatment injection, and immediately notify the physician if symptoms of a generalized reaction or shock occur.


6. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long term studies have not been conducted with allergenic extracts to determine their potential for carcinogenesis, mutagenesis, and impairment of fertility.


7. LACTATION: Data are not available on the secretion of allergenic extract in human milk and it is not known what affect this might have on the nursing infant.


8. PEDIATRIC USE: The dose of allergenic extract recommended for children is the same as that used for adults, except in the injection of large doses of extract for treatment. In this case, the amount of extract given to a child may be modified so that the discomfort of the injection is minimized.

Adverse Reactions

Local Reactions: The occurrence of a hive 5 to 15 minutes after the subcutaneous injection of extract does not require a reduction in dosage. However, a local reaction with edema larger than 2 cm in diameter or swelling and redness that persist for several hours or longer indicates that too much extract has been given. Treatment should be altered as follows:

1. Additional injections should not be given until all evidence of the reaction has disappeared.


2. The next injection administered should be 50% of the last non-reacting dose or less, depending upon the size and severity of the local reaction.


3. Subsequent injections should be continued at the reduced dosage unless the physician responsible for treatment believes that it is safe to increase the dose, and that possible clinical improvement would result form the administration of a larger dose of extract.
   
   

Systemic Reactions:Systemic (generalized) reactions may range from a mild exacerbation of the patient's allergic symptoms to hives, anaphylactic shock, or even death from anaphylaxis. The reaction usually occurs 5 to 20 minutes after injection. As a rule, the more quickly a reaction develops, the more serious it is likely to become. Symptoms may include sneezing, coughing, itching, shortness of breath, abdominal cramps, vomiting, diarrhea, tachycardia, hypotension and respiratory failure in severe cases. The reaction is usually stopped by the subcutaneous injection of Epinephrine HCL 1:1,000 (See Overdosage below). The oral administration of antihistamines and the placement of a tourniquet proximal to the injection site are helpful adjuncts. In the event that additional measures are required, it may be necessary to treat the patient for BRONCHOSPASM with intravenous aminophylline, intravenous fluids and corticosteroids; for HYPOTENSION with vasopressors, volume repletion, isoproterenol and corticosteroids; for LARYNGEAL OBSTRUCTION with oxygen and tracheostomy and for CARDIAC ARREST with cardiopulmonary resuscitation and other appropriate measures.

Immunotherapy after anaphylaxis should be continued if the cause of the reaction can be identified and appropriate precautions taken to insure that a subsequent reaction does not occur.

Overdosage

A strong local reaction to the injection of extract may be treated with oral antihistamines and the local application of a cold compress. The dosage must be reduced and additional extract must not be given until all evidence of the reaction has disappeared.

A systemic reaction following the injection of extract must be treated immediately. Reported procedures include (Ref. #4, vol. 2, p. 888):

1. 0.01 mL/kg up to 0.2 mL of aqueous epinephrine HCL 1:1000 subcutaneously at the injection site of antigen.


2. 0.01 mL/kg up to 0.3 mL of aqueous epinephrine HCL 1:1000 subcutaneously at another site.


3. Diphenhydramine intravenously or intramuscularly, 1.25 mg/kg up to 50 mg.


4. Tourniquet above the injection site of antigen.

Specific reactions:

1. Brochospasm: intravenous aminophylline 4 mg/kg up to 500 mg given over 10 to 15 minutes, aqueous hydrocortisone 5 mg/kg up to 200 mg, oxygen.


2. Laryngeal edema: oxygen, intubation, tracheostomy.


3. Hypotension: vasopressors, fluids, corticosteroids.


4. Cardiac arrest: resuscitation, sodium bicarbonate, defibrillation, antiarrhythmia medications.

Pollen Injection Dosage and Administration

Diagnosis: Concentrated extract may be used for scratch or prick testing providing the patient is not extremely sensitive. In this case, the extract should be diluted 10 fold before a scratch or prick test is performed. Extract for intradermal testing must be used as follows:


a. Patients with a negative scratch or prick test: Patients who do not react who do not react to a valid scratch or prick test should be tested intradermally with 0.05 mL of a 1:1000 v/v dilution of the concentrate. If the test is negative, a second test should be performed with 0.05 mL of a 1:100 v/v dilution or concentrate.

b. Patients with positive scratch or prick tests: It is not advisable to perform an intradermal skin test if the patient has a positive scratch or prick test.

c. Patients tested only by the intradermal method: Patients suspected of being highly allergic should be tested with 0.05 mL of a 1:100,000 v/v dilution of the concentrate. A negative test should be followed by repeat tests using 10 fold stronger concentrations until the maximum dose of 0.05 mL of a 1:100 v/v dilution is reached.


Interpretation of Results

Scratch and Prick Test

A negative test shows only a slight red area at the site of scarification or prick penetration. Positive tests are scored as follows:


1+ Erythema with 5 mm wheal

2+ Erythema with a 5-10 mm wheal

3+ Erythema with a 10-15 mm wheal

4+ Erythema with a wheal 15 mm (or larger) with pseudopodia


Intradermal Test

A negative test shows no change in the appearance and size of the 5 mm wheal created by the I.D. injection of 0.05 mL of extract. Positive tests are scored as follows:


1+ Erythema 10-20 mm with a 5-10 mm wheal

2+ Erythema 20-30 mm with a 5-10 mm wheal

3+ Erythema 30-40 mm with a 10-15 mm wheal

4+ Erythema greater than 40 mm with a 15 mm wheal (or larger) with pseudopodia


Immunotherapy


Allergenic extract should be administered subcutaneously in the outer aspect of the upper arm using a sterile tuberculin syringe and needle. The skin should be cleaned with 70% alcohol and aseptic technique should be observed in removing the extract from the vial. Care must be taken to avoid injecting the extract into a blood vessel because of the risk of anaphylaxis.

Concentrated extract must be diluted before administration to new patients. A 1:100,000 v/v dilution of concentrate is usually satisfactory to start treatment. However, as a precaution against overdose, a skin test with the intended starting dose should be done to help evaluate the patient's sensitivity to the product. If the skin response is larger than 5 mm edema/15 mm erythema, the extract is too strong and must be diluted before it is given subcutaneously. The doses shown in the Dosage Schedule (Table 1) below are recommended unless the patient's skin test response and allergic history indicates that more dilute extract should be used.

Little is known about the required accumulated dosage of allergen that is needed to relieve symptoms. However, studies have shown that high dose immunotherapy is efficacious in the treatment of allergic rhinitis and asthma. For this reason, treatment with extract from Vial #5 is recommended, providing the patient can tolerate the extract without experiencing local or systemic reactions. Treatment with Vial #6 may be used for patients who have not had adverse reactions to extract in Vial #5 and who require more concentrated extract to control or relieve symptoms.

Patients who have received allergenic extract for maintenance therapy SHOULD NOT be given the same dose from a fresh vial of extract. IT IS ADVISABLE TO REDUCE THE DOSAGE OF FRESH EXTRACT TO ONE-FOURTH THE AMOUNT GIVEN FROM A PREVIOUS LOT OF EXTRACT MADE AT THE SAME CONCENTRATION AND BY THE SAME FORMULA.

Table 1 - Suggested Dosage Schedule

No.	Vial #1 1:100,000 w/v frequency twice weekly mL	Vial #2 1:10,000 w/v frequency twice weekly mL	Vial #3 1:1,000 w/v frequency once weekly mL	Vial #4 1:100 w/v frequency once weekly mL	Vial #5 1:10 w/v frequency every two-four weeks mL	Vial #6 Concentrate frequency every two-four weeks mL
1	0.025	0.025	0.025	0.025	0.025	0.025
2	0.05	0.05	0.05	0.05	0.05	0.05
3	0.10	0.10	0.10	0.10	0.10	0.10
4	0.15	0.15	0.15	0.15	0.15	0.15
5	0.20	0.20	0.20	0.20	0.20	0.20
6	0.25	0.25	0.25	0.25	0.25	0.25
7	0.30	0.30	0.30	0.30	0.30	0.30

SUPPLIED

Allergenic extract is supplied in dropper vials for scratch or prick testing and in 10, 30, and 50 mL vials for bulk use.


WARRANTY


Allermed Laboratories, Inc. certifies that allergenic extract prepared within the Laboratories meets the safety and sterility standards of the F.D.A. Because the Laboratories have no control over the conditions under which extract is sued, or the purposes intended, neither a good nor a bad effect following its administration is warranted.

The users of this product should be aware of the potential dangers involved in the injection of allergenic extract and accept the risk of any consequences resulting from such injections.

No representatives of the Laboratories may change this warranty whether written, oral or implied. The buyer or user must assume full responsibility for the product after it leaves the premises of the Laboratories.

REFERENCES

1. Levy, D.A., L.M., Lichtenstein, E.O. Goldstein and K. Ishizaka. Immunologic and cellular changes accompanying the therapy of pollen allergy. J. Clinical Investigations. 50:360, 1971.


2. Evans, R., H. Pence, H. Kaplan and R. Rocklin. The effect of immunotherapy on humoral and cellular response in ragweed hayfever. J. Clinical Investigations. 57:1378, 1976.


3. Ishizaka, K. Cellular events in the IgE antibody response. Adv. In Immunology. 23:50, 1976.


4. Middleton, Elliott, Jr., C.E. Reed and E.F. Ellis (Eds.) Allergy, Principles and Practice Vols. 1&2, C.V. Mosby 1978.


5. Sheldon, J.M., R.G. Lovell and K.P. Matthews. A Manual of Clinical Allergy. W.B. Saunders, 1967.


6. Nelson, H.S. Diagnostic procedures in allergy. I. Allergy skin testing. Ann. Allergy. 51:411, 1983.


7. Norma, P.S., W.L. Winkenwerder and L.M. Lichtenstein. Immunotherapy of hay fever with ragweed antigen E: comparisons with whole pollen extract and placebos. J. Allergy. 42:93, 1968.


8. Milner, F.H. and E.C. Tees. Specific sensitivity to individual grass pollens in some hay fever patients. Clinical Allergy. 2:83, 1972.


9. Frankland, A.W. and R. Augustine. Grass pollen antigens effective in treatment. Clinical Science. 23:95, 1962.


10. Pence, H.L., D.Q. Mitchell, R.L. Greely, B.R. Updegraff and H.A. Selfridge. Immunotherapy for mountain cedar pollinosis: a double-blind controlled study. J. Allergy ad Clinical Immunology. 58:39, 1976.


11. Taylor, W.W., J.L. Ohman, Jr. and F.C. Lowell. Immunotherapy in cat-induced asthma. Double-blind trial with evaluation of bronchial responses to cat allergen and histamine. J. Allergy and Clinical Immunology. 61:283. 1978.


12. Lichtenstein, L.M., M.D. Valentine and A.K. Sobotka. Insect allergies. The state of the art. J. Allergy and Clinical Immunology. 61:268, 1978.


13. Metzger, W.J., E. Turner and R. Patterson. The safety of immunotherapy during pregnancy. J. Allergy and Clinical Immunology. 61:268. 1978.


14. Ouellette, J.J. Emergency management of allergic reactions. Modern Medicine 99, 1975.

ACACIA POLLEN  acacia spp.  injection

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 49643-301 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACACIA POLLEN (ACACIA POLLEN) ACACIA POLLEN 1 g  in 20 mL

Inactive Ingredients Ingredient Name Strength Sodium Chloride 0.25 g  in 100 mL Sodium Bicarbonate 0.125   in 100 mL Glycerin 53 mL  in 100 mL Phenol 0.4 g  in 100 mL Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 49643-301-05 5 mL In 1 VIAL, MULTI-DOSE None 2 49643-301-10 10 mL In 1 VIAL, MULTI-DOSE None 3 49643-301-30 30 mL In 1 VIAL, MULTI-DOSE None 4 49643-301-50 50 mL In 1 VIAL, MULTI-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA102212	03/12/1974

ALDER, WHITE POLLEN  alnus rhombifolia  injection

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 49643-312 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALNUS RHOMBIFOLIA POLLEN (ALNUS RHOMBIFOLIA POLLEN) ALNUS RHOMBIFOLIA POLLEN 1 g  in 20 mL

Inactive Ingredients Ingredient Name Strength Sodium Chloride 0.25 g  in 100 mL Sodium Bicarbonate 0.125   in 100 mL Glycerin 53 mL  in 100 mL Phenol 0.4 g  in 100 mL Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 49643-312-05 5 mL In 1 VIAL, MULTI-DOSE None 2 49643-312-10 10 mL In 1 VIAL, MULTI-DOSE None 3 49643-312-30 30 mL In 1 VIAL, MULTI-DOSE None 4 49643-312-50 50 mL In 1 VIAL, MULTI-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA102212	03/12/1974

ALFALFA POLLEN  medicago sativa  injection

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 49643-300 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEDICAGO SATIVA POLLEN (MEDICAGO SATIVA POLLEN) MEDICAGO SATIVA POLLEN 1 g  in 50 mL

Inactive Ingredients Ingredient Name Strength Sodium Chloride 0.25 g  in 100 mL Sodium Bicarbonate 0.125   in 100 mL Glycerin 53 mL  in 100 mL Phenol 0.4 g  in 100 mL Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 49643-300-05 5 mL In 1 VIAL, MULTI-DOSE None 2 49643-300-10 10 mL In 1 VIAL, MULTI-DOSE None 3 49643-300-30 30 mL In 1 VIAL, MULTI-DOSE None 4 49643-300-50 50 mL In 1 VIAL, MULTI-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA102212	03/12/1974

ALKALI BLITE POLLEN  suaeda spp.  injection

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 49643-414 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUAEDA MOQUINII POLLEN (SUAEDA MOQUINII POLLEN) SUAEDA MOQUINII POLLEN 1 g  in 20 mL

Inactive Ingredients Ingredient Name Strength Sodium Chloride 0.25 g  in 100 mL Sodium Bicarbonate 0.125   in 100 mL Glycerin 53 mL  in 100 mL Phenol 0.4 g  in 100 mL Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 49643-414-05 5 mL In 1 VIAL, MULTI-DOSE None 2 49643-414-10 10 mL In 1 VIAL, MULTI-DOSE None 3 49643-414-30 30 mL In 1 VIAL, MULTI-DOSE None 4 49643-414-50 50 mL In 1 VIAL, MULTI-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA102212	03/12/1974

ALTERNARIA  alternaria alternata  injection

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 49643-101 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (ALTERNARIA ALTERNATA) ALTERNARIA ALTERNATA 1 g  in 10 mL

Inactive Ingredients Ingredient Name Strength Sodium Chloride 0.25 g  in 100 mL Sodium Bicarbonate 0.125   in 100 mL Glycerin 53 mL  in 100 mL Phenol 0.4 g  in 100 mL Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 49643-101-05 5 mL In 1 VIAL, MULTI-DOSE None 2 49643-101-10 10 mL In 1 VIAL, MULTI-DOSE None 3 49643-101-30 30 mL In 1 VIAL, MULTI-DOSE None 4 49643-101-50 50 mL In 1 VIAL, MULTI-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA102212	03/12/1974

AMERICAN ELM POLLEN  ulmus americana  injection

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 49643-417 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS AMERICANA POLLEN (ULMUS AMERICANA POLLEN) ULMUS AMERICANA POLLEN 1 g  in 20 mL

Inactive Ingredients Ingredient Name Strength Sodium Chloride 0.25 g  in 100 mL Sodium Bicarbonate 0.125   in 100 mL Glycerin 53 mL  in 100 mL Phenol 0.4 g  in 100 mL Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging

Lactocal-F

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

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

What are Lactocal-F (prenatal multivitamins)?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

How should I take prenatal vitamins?

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

Never take more than the recommended dose of prenatal vitamins.

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

Take your prenatal vitamin with a full glass of water.

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

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

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

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

What happens if I miss a dose?

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

What happens if I overdose?

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

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

What should I avoid while taking prenatal vitamins?

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

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

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

Prenatal vitamins side effects

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

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

• 
  

  upset stomach;

  
  


• 
  

  headache; or

  
  


• 
  

  unusual or unpleasant taste in your mouth.

  
  

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

What other drugs will affect prenatal vitamins?

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

• 
  

  diuretics (water pills);

  
  


• 
  

  heart or blood pressure medications;

  
  


• 
  

  tretinoin (Vesanoid);

  
  


• 
  

  isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

  
  


• 
  

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

  
  


• 
  

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

  
  

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

More Lactocal-F resources

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

• Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)


• CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal Assure Prescribing Information (FDA)


• CitraNatal Harmony Prescribing Information (FDA)


• Concept DHA Prescribing Information (FDA)


• Docosavit Prescribing Information (FDA)


• Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)


• Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)


• Folcal DHA Prescribing Information (FDA)


• Folcaps Care One Prescribing Information (FDA)


• Gesticare DHA Prescribing Information (FDA)


• Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• Inatal Advance Prescribing Information (FDA)


• Inatal Ultra Prescribing Information (FDA)


• Multi-Nate DHA Prescribing Information (FDA)


• Multi-Nate DHA Extra Prescribing Information (FDA)


• MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)


• Natelle One Prescribing Information (FDA)


• Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)


• Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)


• Paire OB Plus DHA Prescribing Information (FDA)


• PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)


• PreNexa Prescribing Information (FDA)


• PreferaOB Prescribing Information (FDA)


• Prenatal Plus Prescribing Information (FDA)


• Prenatal Plus Iron Prescribing Information (FDA)


• Prenate Elite Prescribing Information (FDA)


• Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)


• Prenate Elite tablets


• Prenate Essential Prescribing Information (FDA)


• PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)


• PrimaCare ONE capsules


• PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)


• Renate DHA Prescribing Information (FDA)


• Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Se-Natal 19 Prescribing Information (FDA)


• Tandem DHA Prescribing Information (FDA)


• Tandem OB Prescribing Information (FDA)


• TriAdvance Prescribing Information (FDA)


• Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Triveen-PRx RNF Prescribing Information (FDA)


• UltimateCare ONE NF Prescribing Information (FDA)


• Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)


• Vinate AZ Prescribing Information (FDA)


• Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Zatean-CH Prescribing Information (FDA)

Compare Lactocal-F with other medications

• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

• Your pharmacist can provide more information about prenatal vitamins.

BritLofex Tablets 0.2mg

1. Name Of The Medicinal Product

BritLofex Tablets 0.2mg

2. Qualitative And Quantitative Composition

Lofexidine hydrochloride 0.2mg

3. Pharmaceutical Form

Film-coated tablet.

Peach coloured, round tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

To relieve symptoms in patients undergoing opiate detoxification.

4.2 Posology And Method Of Administration

The recommended route of administration is by mouth.

ADULTS

The dosage of lofexidine should be titrated according to the patient's response. Initial dosage should be 0.8mg per day in divided doses. The dosage may be increased by increments of 0.4 to 0.8mg per day up to a maximum of 2.4mg daily. Maximum single dose should not exceed 4 x 0.2mg tablets (0.8mg). Each patient should be assessed on an individual basis; those undergoing acute detoxification will usually require the highest recommended dose and dosage increments to provide optimum relief at the time of expected peak withdrawal symptoms.

In cases where no opiate use occurs during detoxification, a duration of treatment of 7-10 days is recommended. In some cases the physician may consider longer treatment is warranted.

CHILDREN:

Safety and effectiveness in children has not been established.

ELDERLY:

There is no experience of dosing in the elderly from clinical studies. Should use in the elderly be necessary it is advised that special caution is observed in the presence of heart disease or anti-hypertensive therapy.

4.3 Contraindications

BritLofex tablets are contraindicated in patients who are allergic to lofexidine or to other imidazoline derivatives or to any excipients of BritLofex.

4.4 Special Warnings And Precautions For Use

As with other hypotensive agents, therapy with lofexidine should not be discontinued abruptly. Dosage should be reduced gradually over a period of 2-4 days or longer, to minimise blood pressure elevation and associated signs and symptoms. Lofexidine should be used with caution in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease or chronic renal failure and in patients with bradycardia or hypotension. Blood pressure and pulse rate should be assessed frequently. Patients with a history of depression should be carefully observed during long-term therapy with lofexidine.

There have been reports of QT prolongation during lofexidine treatment. Whilst the nature of the relationship between lofexidine and these ECG changes is not yet clear, it would be prudent to avoid the use of lofexidine in patients at risk of QT prolongation i.e. those with known QT problems, metabolic disturbances, pre-existing cardiovascular disease, relevant family history or those taking other drugs known to prolong the QT interval.

This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Allergic reactions may occur due to the presence of E110 (Sunset Yellow).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Lofexidine may enhance the CNS depressive effects of alcohol, barbiturates and other sedatives.

Lofexidine may enhance the effects of anti-hypertensive drug therapy.

Concomitant use of tricyclic antidepressants may reduce the efficacy of lofexidine.

Concomitant use of drug which prolong the QT interval or cause electrolyte imbalance should be avoided.

4.6 Pregnancy And Lactation

Pregnancy:

The safety of lofexidine in pregnant women has not been established. High doses of lofexidine given to pregnant dogs and rabbits caused a reduction in foetal weight and increased abortions. Lofexidine should only be administered during pregnancy if the benefit outweighs the potential risk to mother and foetus.

Lactation:

It is not known whether this drug is excreted in human milk and caution should be exercised when it is administered to a nursing woman.

4.7 Effects On Ability To Drive And Use Machines

Lofexidine may have a sedative effect. If affected, patients should be advised not to drive or operate machines.

4.8 Undesirable Effects

The adverse effects of the drug are primarily related to its central alpha-adrenergic agonist effects:

Very common (

Common (

Uncommon (

Rare (

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

Immune system disorders:

Not known:

Allergic reactions may occur due to the presence of E110 (Sunset Yellow).

Nervous system disorders:

Very common:

Dizziness has been reported following treatment with lofexidine.

Drowsiness and related symptoms including sedation and somnolence have been reported.

Cardiac disorders:

Very common:

Bradycardia has been reported.

Not known:

There have been reports of QT prolongation during lofexidine treatment.

Vascular disorders:

Very common:

Hypotension has been reported

General disorders and administration site conditions:

Very common:

Dryness of mucous membranes especially the mouth, throat and nose has been reported.

4.9 Overdose

Overdosage may cause hypotension, bradycardia and sedation. Gastric lavage should be carried out where appropriate. In most cases, all that is required are general supportive measures.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: Drugs used in opioid dependence

ATC Classification: N07BC04

Lofexidine hydrochloride is an orally active imidazoline adrenergic alpha-2-receptor agonist; and is believed to have a high affinity for 2A receptor subtypes resulting in less anti-hypertensive activity than clonidine, a non-selective alpha-2-receptor agonist. Hypotension may occur in susceptible subjects, accompanied by a decrease in heart rate.

Abrupt discontinuation of lofexidine has been, in some cases, associated with a transient increase in blood pressure to higher than pre-treatment levels.

5.2 Pharmacokinetic Properties

Lofexidine is extensively absorbed and achieves peak plasma concentration at 3 hours after administration of a single dose. The elimination half-life is 11 hours with accumulation occurring up to four days with repeat dosing. Lofexidine undergoes extensive metabolism in the liver and excretion is mainly by the kidney.

5.3 Preclinical Safety Data

Animal toxicology. Lofexidine was tolerated at high dosage in singe dose toxicity studies in animals, the LD₅₀ being >77 mg/kg. With repeat dosing in mice, rats and dogs symptoms related to the pharmacology of the drug (ataxia, sedation, tremor, unkempt appearance and exhaustion) appeared.

Studies of mutagenicity are incomplete but lofexidine did not display mutagenicity in the Ames test. Long-term studies in rats showed no evidence of carcinogenicity.

High doses of lofexidine given to pregnant rats and rabbits caused a reduction in the foetal weight and increased abortions. No teratogenic effects were found.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose (monohydrate)

Citric acid

Povidone

Microcrystalline cellulose

Calcium stearate

Sodium lauryl sulphate

Purified water

Film Coat:

Opadry OY-S-9480 Brown

containing

Hydroxypropylmethyl cellulose

Titanium dioxide

Propylene glycol

Indigo Carmine (E132)

Sunset Yellow (E110)

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 25ºC. Store in original package.

6.5 Nature And Contents Of Container

Aluminium foil/aluminium foil blister strips

Aluminium foil/PVC blister strips

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

Britannia Pharmaceuticals Limited

Park View House

65 London Road

Newbury

Berkshire

RG14 1JN

United Kingdom

8. Marketing Authorisation Number(S)

PL 04483/0036

9. Date Of First Authorisation/Renewal Of The Authorisation

October 1990

10. Date Of Revision Of The Text

29 June 2010

Maxidex

1. Name Of The Medicinal Product

MAXIDEX 0.1% w/v, eye drops, suspension

2. Qualitative And Quantitative Composition

Dexamethasone 0.1% w/v

For excipients, see 6.1.

3. Pharmaceutical Form

Eye drops, suspension

4. Clinical Particulars

4.1 Therapeutic Indications

Indicated for treatment of steroid responsive inflammatory conditions of the conjunctiva, cornea and anterior segment of the eye such as: anterior uveitis, iritis, cyclitis, allergic and vernal conjunctivitis, herpes zoster keratitis, superficial punctate keratitis and non-specific superficial keratitis.

Also indicated for the treatment of corneal injury from chemical, radiation or thermal burns or following penetration by foreign bodies. Indicated for post-operative use to reduce inflammatory reactions and suppress graft reaction.

4.2 Posology And Method Of Administration

Adults, adolescents, and children (above 2 years of age)

The frequency of instillation of drops and the duration of treatment will vary depending upon the severity of the underlying condition and the response to treatment.

Severe inflammations require one to two drops instilled into the eye every thirty to sixty minutes until a satisfactory response occurs.

Subconjunctival or systemic steroid therapy should be considered if there is no response. When a favourable response has been observed reduce the dosage towards one drop every four hours.

Paediatric patients

The safety and efficacy of this product has not been established in children below 2 years of age.

4.3 Contraindications

• Vaccinia, varicella, or other viral diseases of cornea and conjunctiva (except herpes zoster keratitis)

• Ocular herpes simplex

• Fungal diseases of ocular structures

• Mycobacterial ocular infections

• Acute, untreated purulent bacterial infections

• Hypersensitivity to dexamethasone or to any of the excipients.

4.4 Special Warnings And Precautions For Use

• For ocular use only.

• Prolonged use of topical ophthalmic corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, reduced visual acuity, visual field defects and posterior subcapsular cataract formation. In patients receiving prolonged ophthalmic corticosteroid therapy, intraocular pressure and the lens should be checked routinely and frequently, particularly in patients with a history or presence of glaucoma.

• Topical corticosteroids should not be used for longer than one week except under ophthalmic supervision, with regular checks of intraocular pressure.

• Corticosteroids may reduce resistance to and aid in the establishment of bacterial, viral and fungal infections and mask the clinical signs of infections, preventing recognition of ineffectiveness of the antibiotic. In such cases antibiotic therapy is mandatory. Fungal infection should be suspected in patients with persistent corneal ulceration who have been or are receiving these drugs, and corticosteroids therapy should be discontinued if fungal infection occurs.

• Topical ophthalmic corticosteroids may slow corneal wound healing.

• In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids.

• Contact lens wear is not recommended during treatment of an ocular inflammation.

• Additionally, this product contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of MAXIDEX and wait at least 15 minutes before reinsertion.

• There is no evidence of safety in use in children under two years of age.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interaction studies have been performed.

If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.

4.6 Pregnancy And Lactation

Pregnancy

There are no or limited amount of data from the use of MAXIDEX in pregnant woman. Studies in animals have shown reproductive toxicity (see section 5.3). Even though, the maximum daily dose (2x 30μl drops x 4 times per day = about 0.240 mg/day dexamethasone) following topical application is much lower than a standard systemic anti-inflammatory dose of about 0.5 to 10mg daily.

MAXIDEX is not recommended during pregnancy unless the clinical condition of the woman requires treatment with MAXIDEX.

Lactation

Systemically administered corticosteroids appear in human milk in quantities that could affect the child being breastfed. However, when instilled topically, systemic exposure is low. It is unknown whether MAXIDEX is excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from MAXIDEX therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

4.7 Effects On Ability To Drive And Use Machines

MAXIDEX has no or negligible influence on the ability to drive and use machines. As with any topical ophthalmic medicinal product, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery.

4.8 Undesirable Effects

Summary of the safety profile

In clinical trials, the most common adverse reaction was ocular discomfort.

Tabulated list of adverse reactions

The following adverse reactions are classified according to the following convention:

very common (

System Organ Classification	MedDRA Preferred Term (v. 12.0)
Immune system disorders	Not known: hypersensitivity
Nervous system disorders	Uncommon: dysgeusia Not known: dizziness, headache
Eye disorders	Common: ocular discomfort Uncommon: keratitis, conjunctivitis, keratoconjunctivitis sicca, corneal staining, photophobia, vision blurred, eye pruritus, foreign body sensation in eyes, lacrimation increased, abnormal sensation in eyes, eyelid margin crusting, eye irritation, ocular hyperaemia Not known: intraocular pressure increased, visual acuity reduced, corneal erosion, eyelid ptosis, eye pain, mydriasis

Description of selected adverse reactions

Prolonged topical ophthalmic corticosteroids may result in increased intraocular pressure with damage to the optic nerve, reduced visual acuity and visual field defects, and to posterior subcapsular cataract formation (see section 4.4).

Due to the corticosteroid component, in diseases causing thinning of the cornea or sclera there is a higher risk for perforation especially after long treatments (see section 4.4).

Corticosteroids may reduce resistance to and aid in the establishment of infections (see section 4.4).

4.9 Overdose

Long-term intensive topical use may lead to systemic effects. Oral ingestion of the contents of the bottle (up to 10 mls) is unlikely to lead to any serious adverse effects.

An ocular overdose of Maxidex can be flushed from the eye(s) with lukewarm water.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: Ophthalmologicals: Anti-inflammatory Agents

ATC Code S01B A01

Dexamethasone has been demonstrated by animal and human studies based on oral application to possess approximately six to seven times the potency of prednisolone and at least 30 times the potency of cortisone. The potency of the compound is accomplished by the addition of a methyl radical and a fluorine atom to the prednisolone radical.

5.2 Pharmacokinetic Properties

Dexamethasone is absorbed rapidly after oral administration with a half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects. In plasma dexamethasone protein binding is less than for most other corticosteroids. Corticosteroids diffuse into tissue fluids and cerebrospinal fluid but transplacental diffusion in significant amounts has not been demonstrated. Corticosteroids are metabilised in the liver the kidney and excrete in the urine. Metabolism is similar to other corticosteroids. Intraocular penetration occurs in significant amounts and contributes to the effectiveness of dexamethasone in anterior segment inflammatory disease.

5.3 Preclinical Safety Data

Repeat dose topical ocular safety studies with dexamethasone in rabbits have shown systemic corticosteroid effects. Such effects are considered to be unlikely when MAXIDEX is used as recommended.

Dexamethasone was clastogenic in the in vitro human lymphocyte assay and in vivo in the mouse micronucleus assay at doses in excess of those obtained following topical application. Conventional carcinogenicity studies with MAXIDEX have not been performed.

Dexamethasone has been found to be teratogenic in animal models. Dexamethasone induced abnormalities of foetal development including cleft palate, intra-uterine growth retardation and affects on brain growth and development.

There are no other preclinical data of relevance to the prescriber which are additional to that included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium phosphate

Polysorbate 80

Disodium edetate

Sodium chloride

Benzalkonium chloride

Hypromellose

Citric acid

Purified water

6.2 Incompatibilities

None known

6.3 Shelf Life

20 months (unopened), 1 month (after first opening).

6.4 Special Precautions For Storage

Do not store above 25°C.

Do not refrigerate or freeze

Keep container tightly closed.

Discard 1 month after first opening.

Store in the original package.

6.5 Nature And Contents Of Container

Drop-Tainer - 5ml and 10ml Natural Low Density Polyethylene Bottles and Plugs.

Polystyrene or Polypropylene cap.

6.6 Special Precautions For Disposal And Other Handling

Do not touch dropper tip to any surface as this may contaminate the contents.

If the drop of medication is not retained in the eye upon dosing for any reason then instill another drop.

7. Marketing Authorisation Holder

Alcon Laboratories (UK) Ltd.,

Pentagon Park,

Boundary Way,

Hemel Hempstead,

HP2 7UD.

8. Marketing Authorisation Number(S)

PL 0649/5914R

9. Date Of First Authorisation/Renewal Of The Authorisation

28/09/1990 / 17/09/2003

10. Date Of Revision Of The Text

20/07/2010