Akrimax Pharmaceuticals, Llc

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Akrimax Pharmaceuticals, Llc Drugs

Primlev

Primlev

Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. PRIMLEVTM is given orally.

The usual adult dosage of PRIMLEVTM is as follows. The total daily dose of acetaminophen should not exceed 4 grams.

Strength

Usual Adult Dose

Maximal Daily Dose

5 mg/300 mg

One Tablet every 6 hours as needed for pain

12 Tablets

7.5 mg/300 mg

One Tablet every 6 hours as needed for pain

8 Tablets

10 mg/300 mg

One Tablet every 6 hours as needed for pain

6 Tablets

Cessation of Therapy

In patients treated with PRIMLEVTM for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.
Tirosint

Tirosint

2.1 Important Information Before Use

Do not cut or crush TIROSINT capsules; capsules should be swallowed whole.

Administer TIROSINT as a single daily dose, preferably one-half to one hour before breakfast. Administer at least 4 hours before or after drugs and foods that are known to interfere with TIROSINT absorption [See Drug Interactions (7.1, 7.9) and Clinical Pharmacology (12.3)].

2.2 Principles of Dosing

The goal of replacement therapy is to achieve and maintain a clinical and biochemical euthyroid state. The goal of suppressive therapy is to inhibit growth and/or function of abnormal thyroid tissue. The dose of TIROSINT that is adequate to achieve these goals depends on a variety of factors including the patient's age, body weight, cardiovascular status, concomitant medical conditions, pregnancy status, concomitant medications, and the specific nature of the condition being treated.

Hence, the following recommendations serve only as dosing guidelines. Dosing must be individualized and adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters. Inadequate levothyroxine dosage will fail to ameliorate the signs and symptoms of hypothyroidism [See Warnings and Precautions (5.1)].

Due to the long half-life of levothyroxine, the peak therapeutic effect at a given dose of levothyroxine sodium may not be attained for 4-6 weeks.

2.3 Dosing In Specific Patient Populations

Hypothyroidism in Adults and in Adolescents in Whom Growth and Puberty are Complete

The average full replacement dose of levothyroxine sodium is approximately 1.7 mcg per kg per day (e.g., 100-125 mcg per day for a 70 kg adult). Elderly patients may require less than 1 mcg per kg per day.

The initial levothyroxine dosage is based on the age, weight, and cardiac status of the patient as well as the severity and duration of the hypothyroidism. Therapy may generally begin at full replacement doses in otherwise non-elderly, healthy individuals.

For elderly patients or those with underlying cardiovascular disease, a starting dose of levothyroxine sodium as low as 12.5 mcg per day may be appropriate, with gradual increments in dose at 6-8 week intervals, as needed [See Warnings and Precautions (5.2)]. More frequent monitoring is recommended for patients with more severe hypothyroidism.

In general, levothyroxine sodium doses greater than 200 mcg per day are seldom required. An inadequate response to daily doses greater than 300 mcg per day is rare and may indicate poor compliance, malabsorption, and/or drug interactions.

Secondary or Tertiary Hypothyroidism

In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism, the levothyroxine sodium dose should be titrated until the patient is clinically euthyroid and the serum free thyroxine (FT4) level is restored to the upper half of the normal range.

Hypothyroidism (Congenital or Acquired) in the Pediatric Population

Only administer TIROSINT to children who are able to swallow an intact capsule [See Contraindications (4)].

In general, levothyroxine therapy should be instituted at full replacement doses as soon as possible. Delays in diagnosis and institution of therapy may have deleterious effects on the child's intellectual and physical growth and development. Undertreatment and overtreatment should be avoided [See Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

Levothyroxine therapy is usually initiated at full replacement doses, with the recommended dose per body weight changing with age (Table 1).
Table 1: Levothyroxine Sodium Dosing Guidelines for Pediatric Hypothyroidism Age Daily Dose Per Kg Body Weight* * The dose should be adjusted based on clinical response and laboratory parameters. [See Warnings and Precautions (5.1) and Use in Specific Populations (8.4)] 6-12 years 4-5 mcg/kg/day >12 years but growth and puberty incomplete 2-3 mcg/kg/day Growth and puberty complete 1.7 mcg/kg/day
In children with chronic or severe hypothyroidism, a lower initial dose of 25 mcg per day of levothyroxine sodium is recommended with increasing increments of 25 mcg every 2-4 weeks until the desired effect is achieved.

Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose, and the dose is then increased on a weekly basis by an amount equal to one-fourth the full-recommended replacement dose until the full recommended replacement dose is reached.

Pregnancy

Pregnancy may increase levothyroxine requirements. [See Use in Specific Populations (8.1)]

Thyrotropin-Stimulating Hormone (TSH) Suppression in Well-Differentiated Thyroid Cancer

In the treatment of well-differentiated (papillary and follicular) thyroid cancer, levothyroxine is used as an adjunct to surgery and radioiodine therapy. Generally, TSH is suppressed to less than 0.1 mU per L, and this usually requires a levothyroxine sodium dose of greater than 2 mcg per kg per day. However, in patients with high-risk tumors, the target level for TSH suppression may be less than 0.01 mU per L.

Myxedema Coma

Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Therefore, thyroid hormone administered intravenously is the recommended route of administration in this rare condition.

2.4 Monitoring TSH and/or Thyroxine (T4) Levels

The adequacy of therapy is determined by periodic assessment of appropriate laboratory tests and clinical evaluation. The choice of laboratory tests depends on various factors including the etiology of the underlying thyroid disease, the presence of concomitant medical conditions, including pregnancy, and the use of concomitant medications. Persistent clinical and laboratory evidence of hypothyroidism despite an apparent adequate replacement dose of TIROSINT may be evidence of inadequate absorption, poor compliance, drug interactions, or decreased T4 potency of the drug product.

Adults

In adult patients with primary (thyroidal) hypothyroidism, serum TSH levels alone may be used to monitor therapy. The frequency of TSH monitoring during levothyroxine dose titration depends on the clinical situation but reassessment and titration should be done after an interval of at least 6 weeks after any change in dose. When the optimum replacement dose has been attained, clinical (physical examination) and biochemical monitoring may be performed every 6-12 months, depending on the clinical situation, and whenever there is a change in the patient's status. It is recommended that a physical examination and a serum TSH measurement be performed at least annually in patients receiving TIROSINT.

Pediatrics

In patients with congenital hypothyroidism, the adequacy of replacement therapy should be assessed by measuring both serum TSH and total or FT4. While the aim of therapy is to also normalize the serum TSH level, this is not always possible in a small percentage of patients, particularly in the first few months of therapy. TSH may not normalize due to a resetting of the pituitary-thyroid feedback threshold as a result of in utero hypothyroidism. Failure of the serum T4 to increase into the upper half of the normal range within 2 weeks of initiation of TIROSINT therapy and/or of the serum TSH to decrease below 20 mU per L within 4 weeks should alert the physician to the possibility that the child is not receiving adequate therapy. Careful inquiry should then be made regarding compliance, dose of medication administered, and method of administration prior to increasing the dose of TIROSINT.

The recommended frequency of monitoring of TSH and total or FT4 in children is as follows: at 2 and 4 weeks after the initiation of treatment and following dose stabilization every 3 to 12 months thereafter until growth is completed. More frequent intervals of monitoring may be necessary if poor compliance is suspected or abnormal values are obtained. It is recommended that TSH and T4 levels, and a physical examination, if indicated, be performed 2 weeks after any change in TIROSINT dosage. Routine clinical examination, including assessment of mental and physical growth and development, and bone maturation, should be performed at regular intervals [See Warnings and Precautions (5.1), and Use in Specific Populations (8.4)].

Secondary (Pituitary) and Tertiary (Hypothalamic) Hypothyroidism

Adequacy of therapy should be assessed by measuring serum FT4 levels, which should be maintained in the upper half of the normal range in these patients.
Suprenza

Suprenza

Exogenous Obesity

Dosage should be individualized to obtain an adequate response with the lowest effective dose.

The usual adult dose is one tablet as prescribed by the physician, administered in the morning, with or without food. Suprenza is not recommended for use in pediatric patients less than or equal to 16 years of age.

Late evening medication should be avoided because of the possibility of resulting insomnia.

With dry hands, gently remove the Suprenza (phentermine hydrochloride ODT) tablet from the bottle. Immediately place the Suprenza tablet on top of the tongue where it will dissolve, then swallow with or without water.
Primlev

Primlev

Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effects of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. PRIMLEVTM is given orally.

The usual adult dosage of PRIMLEVTM is as follows. The total daily dose of acetaminophen should not exceed 4 grams.

Strength

Usual Adult Dose

Maximal Daily Dose

5 mg/300 mg

One Tablet every 6 hours as needed for pain

12 Tablets

7.5 mg/300 mg

One Tablet every 6 hours as needed for pain

8 Tablets

10 mg/300 mg

One Tablet every 6 hours as needed for pain

6 Tablets

Cessation of Therapy

In patients treated with PRIMLEVTM for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.
Nitromist

Nitromist

2.1 Recommended Dosage

At the onset of an attack, one metered spray or two metered sprays should be administered on or under the tongue. A spray may be repeated approximately every 5 minutes as needed. If two sprays are used initially, the patient may only administer one more spray after waiting 5 minutes. No more than 3 metered sprays are recommended within a 15-minute period. If chest pain persists after a total of 3 sprays, prompt medical attention is recommended. NitroMist may be used prophylactically 5 minutes to 10 minutes before engaging in activities that might precipitate an acute attack.

2.2 Priming the Container

After an initial priming of 10 sprays, each metered spray of NitroMist delivers 33 mg of solution containing 400 mcg of nitroglycerin. It will remain adequately primed for 6 weeks. If the product is not used within 6 weeks, it can be adequately re-primed with 2 sprays. NitroMist is available in either 230 metered sprays or 90 metered sprays per container, but the total number of available doses depends on the number of sprays per use (1 spray or 2 sprays), and the frequency of priming.

2.3 Administration

During use the patient should rest, ideally in the sitting position. The container should be held vertically with the valve head uppermost and the spray orifice as close to the mouth as possible. The dose should preferably be sprayed into the mouth on or under the tongue by pressing the button firmly and the mouth should be closed immediately after each dose. THE SPRAY SHOULD NOT BE INHALED. Patients should be instructed to familiarize themselves with the position of the spray orifice, which can be identified by the finger rest on top of the valve, in order to facilitate orientation for administration at night.
Do not shake container. Remove plastic cap. If this is the first time using the bottle, press actuator button 10 times to ensure proper dose priming (holding unit away from yourself and others). Hold container upright with forefinger on top of the actuator button. Open mouth and bring the container as close as possible. Press the actuator button firmly with forefinger to release spray(s) onto or under the tongue. Release button and close mouth. The medication should not be spit out or the mouth rinsed for 5 minutes to 10 minutes following administration. If a second administration is required to obtain relief, repeat steps 4, 5, and 6. No more than 3 metered sprays can be given within a 15-minute period. Replace plastic cover. If the product is not used for more than 6 weeks, then it can be adequately re-primed with 2 sprays.
The level of the liquid in the container should be periodically checked. While the container is in the upright position, if the liquid reaches the top or middle of the hole on the side of the container, one should order more. When the liquid reaches the bottom of the hole, the remaining doses will have less than label content.
Inderal La

Inderal La

General

Inderal® LA provides propranolol hydrochloride in a sustained-release capsule for administration once daily. If patients are switched from Inderal Tablets to Inderal LA Capsules, care should be taken to assure that the desired therapeutic effect is maintained. Inderal LA should not be considered a simple mg-for-mg substitute for Inderal. Inderal LA has different kinetics and produces lower blood levels. Retitration may be necessary, especially to maintain effectiveness at the end of the 24-hour dosing interval.

Hypertension

The usual initial dosage is 80 mg Inderal LA once daily, whether used alone or added to a diuretic. The dosage may be increased to 120 mg once daily or higher until adequate blood pressure control is achieved. The usual maintenance dosage is 120 to 160 mg once daily. In some instances a dosage of 640 mg may be required. The time needed for full hypertensive response to a given dosage is variable and may range from a few days to several weeks.

Angina Pectoris

Starting with 80 mg Inderal LA once daily, dosage should be gradually increased at three- to seven-day intervals until optimal response is obtained. Although individual patients may respond at any dosage level, the average optimal dosage appears to be 160 mg once daily. In angina pectoris, the value and safety of dosage exceeding 320 mg per day have not been established.

If treatment is to be discontinued, reduce dosage gradually over a period of a few weeks (see "WARNINGS").

Migraine

The initial oral dose is 80 mg Inderal LA once daily. The usual effective dose range is 160 to 240 mg once daily. The dosage may be increased gradually to achieve optimal migraine prophylaxis. If a satisfactory response is not obtained within four to six weeks after reaching the maximal dose, Inderal LA therapy should be discontinued. It may be advisable to withdraw the drug gradually over a period of several weeks depending on the patient's age, comorbidity, and dose of Inderal LA.

Hypertrophic Subaortic Stenosis

The usual dosage is 80 to 160 mg Inderal LA once daily.
Innopran Xl

Innopran Xl

INNOPRAN XL should be administered once daily at bedtime and should be taken consistently either on an empty stomach or with food. Initiate dosing at 80 mg and titrate to 120 mg daily as needed for blood pressure control. Doses above 120 mg have no additional effects on blood pressure [see Clinical Studies (14.1)]. The time needed for full antihypertensive response is variable, but is usually achieved within 2 to 3 weeks.
Norgestrelethinyl Estra...

Norgestrelethinyl Estradiol Kit

To achieve maximum contraceptive effectiveness, NORGESTREL/ETHINYL ESTRADIOL must be taken exactly as directed and at intervals not exceeding 24 hours.

The dosage of NORGESTREL/ETHINYL ESTRADIOL is one white tablet daily for 21 consecutive days, followed by one pink inert tablet daily for 7 consecutive days, according to prescribed schedule. It is recommended that NORGESTREL/ETHINYL ESTRADIOL tablets be taken at the same time each day.

During The First Cycle of Use

The possibility of ovulation and conception prior to initiation of medication should be considered. The patient should be instructed to begin taking NORGESTREL/ETHINYL ESTRADIOL on either the first Sunday after the onset of menstruation (Sunday Start) or on Day 1 of menstruation (Day 1 Start).

Sunday start:

The patient is instructed to begin taking NORGESTREL/ETHINYL ESTRADIOL on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 21 consecutive days followed by one pink inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within 3 days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle, contraceptive reliance should not be placed on NORGESTREL/ETHINYL ESTRADIOL until a white tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control should be used during those 7 days.

Day 1 start:

During the first cycle of medication, the patient is instructed to begin taking NORGESTREL/ETHINYL ESTRADIOL during the first 24 hours of her period (day one of her menstrual cycle). One white tablet should be taken for 21 consecutive days, followed by one pink inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within 3 days following discontinuation of white tablets and may not have finished before the next pack is started. If medication is begun on day one of the menstrual cycle, no back-up contraception is necessary. If NORGESTREL/ETHINYL ESTRADIOL tablets are started later than day one of the first menstrual cycle or postpartum, contraceptive reliance should not be placed on NORGESTREL/ETHINYL ESTRADIOL tablets until after the first 7 consecutive days of administration, and a non-hormonal back-up method of birth control should be used during those 7 days.

After the first cycle of use

The patient begins her next and all subsequent courses of tablets on the day after taking her last pink tablet. She should follow the same dosing schedule: 21 days on white tablets followed by 7 days on pink tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.

Switching from another hormonal method of contraception

When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts NORGESTREL/ETHINYL ESTRADIOL. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of NORGESTREL/ETHINYL ESTRADIOL -on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin NORGESTREL/ETHINYL ESTRADIOL the next day. If switching from an implant or injection, the patient should start NORGESTREL/ETHINYL ESTRADIOL on the day of implant removal or the day the next injection would be due. In switching from a progestin-only pill, injection, or implant, the patient should be advised to use a non-hormonal back-up method of birth control for the first 7 days of tablet-taking.

If spotting or breakthrough bleeding occurs

If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician.

Risk of pregnancy if tablets are missed

While there is little likelihood of ovulation occurring if only one or two white tablets are missed, the possibility of ovulation increases with each successive day that scheduled white tablets are missed. Although the occurrence of pregnancy is unlikely if NORGESTREL/ETHINYL ESTRADIOL is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.

The risk of pregnancy increases with each active (white) tablet missed. For additional patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in the DETAILED PATIENT LABELING below.

Use after pregnancy, abortion, or miscarriage

NORGESTREL/ETHINYL ESTRADIOL may be initiated no earlier than day 28 postpartum in the nonlactating mother or after a second-trimester abortion due to the increased risk for thromboembolism (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet-taking.

NORGESTREL/ETHINYL ESTRADIOL 28 may be initiated immediately after a first-trimester abortion or miscarriage. If the patient starts NORGESTREL/ETHINYL ESTRADIOL immediately, back-up contraception is not needed.

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Akrimax Pharmaceuticals, Llc Drugs